28

MEDICAL DEVICE REGULATION CERTIFICATION PROCEDURE
1. PURPOSE
The objective of this procedure is to set down methods to be applied during the phases of
application acceptance, technical examinations, audits and drawing up and submitting the
certificates of the bodies that are entitled to obtain Product Certification in accordance with
Medical Device Regulation 2017/745/EU (MDR).
2. RESPONSIBLES
 General Manager (GM)

 Medical Device Technical Regulation Responsible (MDTRR)
 Management Representative
 Project Leader
 Internal Clinician
 Decision-maker(s)
 Final Reviewer(s)
 Planning Responsible (PR),
 Certification Committee (CC),
 Product reviewers, Site Auditors, Clinical Experts
 Certificate Printing Unit (CPU),
 Secretariat.
3. DEFINITIONS:
Client: Refers to the legal entity applying in order to get Product Certification service from
UDEM ADRIATIC D.O.O.
Audit Team: Refers to the team appointed so as to analyze and assess QMS and technical
documentation and/or quality management system of the bodies in terms of Product
Certification activity, selected from UDEM ADRIATIC D.O.O. UDLST.07 MDR Conformity
Assessment Personnel Matrix. They work in accordance with the UDEM ADRIATIC D.O.O.
working principals. They are formed provisionally and consist of different auditors and
product reviewer depending on the audit type.
CPA: Corrective and/or Preventive Action
Technical Documentation: The documents and reports related with the device in question
and consist of the required documents specified in Annex II and Annex III of MDR
Supplier/Subcontractor Audit: A service / product / process audit that is carried out on a
different basis from the facilities of the manufacturer having legal responsibility in the
lifecycle of the medical device.
Conformity Assessment: means the process demonstrating whether the requirements of
Medical Devices Regulation 2017/745/EU relating to a device have been fulfilled;
UDEM Adriatic d.o.o

www.udemadriatic.com
UDPD.04/ 06-03.06.2020/04.01.2018/Page:1/49
4. REFERENCE
This procedure was prepared within EN ISO 17065 system of UDEM ADRIATIC D.O.O. on the
basis of 2017/745/EU Medical Devices Regulation, for the audits and assessments
performed by UDEM ADRIATIC D.O.O. in the field of medical devices
-Harmonized Standards and Common Specification(s)
-MDCG Documents
-Other guidance documents published by EC about the implementation of MDR
5. PROCUREMENT OF THE PRE-APPLICATION and APPLICATION PROCESS
5.1 Receipt of Pre-Application
Companies wanting to receive services from our organization may reach UDEM ADRIATIC
D.O.O. by phone, e-mail or in person. FRM.81 Medical CE Application Form is sent to these
companies by medical unit planning executives via e-mail or the related form may be
downloaded from www.udemadriatic.com web site. With the FRM.81 Medical CE
Application Form, the manufacturer provides technical information about the medical
device it seeks conformity assessment service and the information that will provide
feedback at the pre-application and application review stage to the UDEM ADRIATIC D.O.O.
via e-mail or shipping. Manufacturer signs FRM.81 Medical CE Application Form and
accepts its commitments in said form.
5.1.1. Pre-Application Documents:
FRM.81 Medical Devices Certification Application Form (Also, on web site available)
UDFRM.04-01 Application Requirements* (Also, on web site available)
UDTLM.17-1 MDR-Conformity Assessment Charging Instruction** (available on web site)
*UDFRM.04-01 contains the description of the application procedure by which

manufacturers can obtain certification from it, as well as information about the acceptable
language (English) for submission of the documentation and this document is published in
the documentation section of the UDEM ADRIATIC D.O.O.’s web site.
(www.udemadriatic.com)
**UDTLM.17-1 contains detailed information about the fees charged for specific conformity
assessment activities and other financial conditions of UDEM ADRIATIC D.O.O.’s assessment
activities for devices, and this document is published in the documentation section of the
UDEM ADRIATIC D.O.O.’s web site. (www.udemadriatic.com)
UDEM Adriatic d.o.o

UDPD.04/ 06-03.06.2020/04.01.2018/Page:2/49
5.1.2. Commitment to Be Taken During Pre-Application and Contract
The information and the commitments which will be made for UDEM ADRIATIC D.O.O. by
medical device manufacturers/ authorized representatives during the pre-application and
contract (application), will include absolutely the following points within the scope of
Medical Device Regulation:
The manufacturer makes an application to UDEM ADRIATIC D.O.O. for the evaluation of
Quality Management System and technical documentation. The following commitments are
taken from manufacturer with the application form in the pre-application stage:
- Commitment of the manufacturer to fulfil the requirements of the approved quality system.
- A written declaration about not be made any application to another notified body for the
same medical devices.
-The commitment of the manufacturer about the approved quality system which will be
continued effectively and completely.
-If the company has a certificate from another notified body about the same medical devices,
the NB must give a commitment to share the certification date, information about the
surveillance audits, past audits results with UDEM ADRIATIC D.O.O.
- According to the Medical Device Regulation and the medical device, as part of a whole
human blood derivative or a declaration whether containing a substance or not and
considering the intended purpose of the medical device, the commitment must be taken
about the sharing of data which is needed to evaluate the test results, the usefulness, quality
and reliability of human blood derivative or substance.
- In medical device manufacturing, a declaration on the use of animal-derivative tissue
according to the regulations regarding animal-derivative tissue.
The following commitments are taken from manufacturer with the contract (application):
- UDEM ADRIATIC D.O.O. can make unannounced audits to the manufacturer. During these
visits, if necessary, UDEM ADRIATIC D.O.O. can perform or make manufacturer tests to check
that the quality system is working well. UDEM ADRIATIC D.O.O. gives an audit report and if
applicable a test report.
Post-production stage medical device obtained from the data, Annex XIV of MDR in the
provisions, including, reviewing, necessary corrective actions implementation of a system to
be created and the system kept up to date on the industry commitment.
-The review of the data which are obtained at post- production stage, including the
provisions of MDR Annex XIV, creation of a system for the implementation of required
corrective action and commitment of manufacturer to keep the system current. This
commitment includes the obligation to notify the competent authorities (ministry of
health/HALMED) from the moment the manufacturer has information about the following
items:
a) Which led serious deterioration or could lead to death at state of health of the patient or
user;
UDEM Adriatic d.o.o
UDPD.04/ 06-03.06.2020/04.01.2018/Page:3/49
1) Degradation or deviation of properties of the medical device and / or performance,

2) Manual and deficiency on the label,
b) Because of the reasons which has been determined in (a) article, the technical and
medical reasons depending on the properties and performance of medical devices which led
to the withdrawal from the market systematically by the same type medical device
manufacturer.
5.2. Pre-Application and Application Review Process:
5.2.1. Pre-Application
5.2.1.1 Review of Pre-Application
After entering into the system with the code Planning Responsible gives to the client (e.g.:
MD.XXXX) according to PD.02 Control of Documents Procedure, then he/she delivers the
application form and any other documents, which are sent with the application form, to the
Medical Device Technical Regulatory Responsible. MDTRR checks the completeness of each
section of the application form. If the application form is filled by the manufacturer fully,
then s/he will review the pre-application. If any necessary part of the application form is not
filled by the manufacturer, then s/he informs the planning responsible. Planning
Responsible asks the manufacturer to fill the empty parts of the application form by E-mail.
After all parts of the application form are filled correctly, then Planning Responsible delivers
the application and other documents to the MDTRR. MDTRR starts the pre-application
review process.
During the review of the pre-application made under the Medical Device Regulation, the
Medical Device Technical Regulatory Responsible (MDTRR) shall;
 First, check whether the product(s) within the scope of the application is a medical
device in the scope of MDR or not; in accordance with UDTLM.19 Medical Device
Classification Instruction. If the product(s) are not a medical device, then the
relevant part in the FRM.82-2 MDR Pre-Application Review Form is marked and
the form is sent to the Planning Responsible. The customer is notified by Planning
Responsible via e-mail.
 Check whether the product(s) in the application form is within the scope of the UDEM
ADRIATIC D.O.O. If the referenced product is not covered by the UDEM ADRIATIC
D.O.O., the relevant part in the FRM.82-2 MDR Pre-Application Review Form is
marked and the form is sent to planning Responsible. The customer is notified by
Planning Responsible via e-mail.
 Determine the MDR and/or MDS and MDT codes for the applied device(s). In order to
determine the MDR and/or MDS and MDT codes MDTRR shall follow the hierarchical
orders of the codes. In order to do so s/he shall review all codes from top to the
bottom. If any active device does not fit in any code, which is listed above MDA 0318
“Other active non-implantable devices”, then the code of the device is determined as
MDA 0318. The same logic also applies for non-active non-implantable devices, in
that case the code is MDN 1214 “General non-active non-implantable devices used in
health care and other non-active non-implantable devices”
UDEM Adriatic d.o.o
UDPD.04/ 06-03.06.2020/04.01.2018/Page:4/49
 Verify the respective classification(s) of the product(s) in accordance with UDTLM. 19

Medical Device Classification Instruction.
 Check the chosen conformity assessment route according to the section 5.2.1.2 of this
procedure.
 Check the availability of sufficient and appropriate resources
 Review the outsourced production processes specified by the manufacturer in the
FRM.81 Medical Devices Certification Application Form.
 Review the presence of sterile barrier systems and the sterilization method
 Review, if it is a pre-certified product, certificate and validity of previous notified
body
 Technical standards and CS(s) regarding the product are checked with the presence
of ISO 13485 QMS certificate.
 Whether the relevant medical device is covered by another legislation is checked.
 If there shall be a technical documentation sampling, number of technical
documentations to be sampled is determined by the UDTLM.50 MDR-Technical
Documentation Assessment Instruction.
 By checking the number of employees, the audit period is calculated in accordance
with TLM 04-1 MDR-Product Certification Audit Duration Determination
Instruction both for initial certification, surveillance and recertification.
 Check that the FRM.81 Medical Devices Certification Application Form is signed
by the manufacturer or its authorized representative and not by any other
organization
All records related to this stage are transferred to the FRM.82-2 Medical CE Pre-
Application Review Form by the MDTRR and if the relevant application is to be passed to
the offer stage, “Pre-Application Approval” section is signed. If the related application is not
within the scope of UDEM ADRIATIC D.O.O., “denied” section is signed and the form is
delivered to planning Responsible. All abovementioned information is necessary to prepare
an offer for the client.
The FRM.82-2 MDR Pre-Application Review Form is sent to the client by the planning
Responsible together with the offer. Customer feedback is provided to check that any
misunderstanding in any information provided by the potential client presents or not.
5.2.1.2 Conformity Assessment Control Method During the Pre-Application Review
In accordance with which annex of the Medical Device Regulation the conformity assessment
process is to be carried out, at the request of the customer, is evaluated by the Medical
Device Technical Regulatory Responsible during the pre-application review.
Medical Device Regulation Annex IX (Chapter I and III), Annex IX (Chapter II) or Annex XI
(Part A) within the scope of UDEM ADRIATIC D.O.O. via the manufacturer is chosen in
FRM.81 Medical Devices Certification Application Form. The accuracy of this selection is
controlled by the Medical Device Technical Regulatory Responsible in accordance with the
following principles.
UDEM Adriatic d.o.o

UDPD.04/ 06-03.06.2020/04.01.2018/Page:5/49
The manufacturers with the following conditions can apply for a conformity assessment
regarding to Annex IX (I) and Annex IX (II). If the manufacturer has an EU Quality
Management system certificate according to Annex IX (I) from a designated NB, then the
manufacturer can apply for an EU technical documentation assessment certificate according
to Annex IX (II) or vice versa situation can be possible.
1- Manufacturers of class III devices, other than custom-made or investigational devices,

can be subject to a conformity assessment in Annex IX of MDR.
2- Manufacturers of class IIb devices, other than custom-made or investigational
devices, can be subject to a conformity assessment as specified in Chapters I and III of
Annex IX of MDR, and including an assessment of the technical documentation as
specified in Section 4 of Annex IX of MDR of at least one representative device per
generic device group. However, for class IIb implantable devices, except sutures,
staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires,
pins, clips and connectors, the assessment of the technical documentation as specified
in Section 4 of Annex IX shall apply for every device.
3- Manufacturers of class IIa devices, other than custom-made or investigational
devices, can be subject to a conformity assessment as specified in Chapters I and III of
Annex IX, and including an assessment of the technical documentation as specified in
Section 4 of that Annex of at least one representative device for each category of
devices. The assessment of the technical documentation shall apply for at least one
representative device for each category of devices.
4- In the case of class I devices placed on the market in sterile condition, have a
measuring function or are reusable surgical instruments, the manufacturer can apply
the procedures set out in Chapters I and III of Annex IX.
The manufacturers with the following conditions can apply for a conformity assessment
regarding to Annex XI (Part A);
1- Manufacturers of class IIa devices, other than custom-made or investigational

devices, can draw up the technical documentation set out in Annexes II and III
coupled with a conformity assessment as specified in Section 10 of Part A of Annex XI
of MDR.
2- Manufacturers of class I devices placed on the market in sterile condition, have a
measuring function or are reusable surgical instruments, can apply the procedures
set out in Part A of Annex XI. However, the involvement of UDEM ADRIATIC D.O.O. in
those procedures is limited: (a) in the case of devices placed on the market in sterile
condition, to the aspects relating to establishing, securing and maintaining sterile
conditions;
(b) in the case of devices with a measuring function, to the aspects relating to the
conformity of the devices with the metrological requirements;
(c) in the case of reusable surgical instruments, to the aspects relating to the reuse of
the device, in particular cleaning, disinfection, sterilization, maintenance and
functional testing and the related instructions for use.
3- Manufacturers of custom-made devices shall follow the procedure set out in Annex
XIII and draw up the statement set out in Section 1 of Annex XI before placing such
devices on the market. In addition to the procedure applicable pursuant to the first
UDEM Adriatic d.o.o
UDPD.04/ 06-03.06.2020/04.01.2018/Page:6/49
subparagraph, manufacturers of class III custom-made implantable devices can apply

a conformity assessment as specified in Part A of Annex XI.
4- Manufacturers of class III devices, if the manufacturer has EU type-examination
certificates referred to in Section 4 of Annex X of MDR, can apply a conformity
assessment as specified in Part A of Annex XI of MDR
5- Manufacturers of class IIb devices, other than custom-made or investigational
devices, if the manufacturer has EU type-examination certificates referred to in
Section 4 of Annex X of MDR, can be subject to a conformity assessment as specified
in Part A of Annex XI of MDR
All records related to this stage are transferred to the FRM.82-2 MDR Pre-Application
Review Form by the Medical Device Technical Regulatory Responsible.
5.2.1.3 Issuing offer for the potential Client:
After review of the pre-application, the UDFRM.179 MDR Offer Form is prepared in
accordance with UDTLM.17-1 MDR-Conformity Assessment Charging Instruction and by
considering the records taken in FRM.82-2 Pre-Application Review Form by MDTRR.
UDFRM.179 Product Certification Proposal form is sent to the customer via e-mail by
Planning Responsible to the e-mail address specified in the FRM.81 Medical Devices
Certification Application Form and information about the approval status of the proposal
is requested. In the event that the proposal is approved by the customer, the process of
drafting the contract begins, and if the customer requests a discount at this stage, the related
request shall be forwarded by the Planning Responsible to the MDTRR. In accordance with
UDTLM.17-1 MDR-Conformity Assessment Charging Instruction, the Medical Device
Technical Regulatory Responsible submits the relevant request to UDEM ADRIATIC D.O.O. to
the General Manager and if in accordance with the UDTLM.17-1 MDR-Conformity
Assessment Charging Instruction a discount is applied, prepares the UDFRM.179 Product
Certification Proposal form with price information and ensures that it is communicated to
the customer in accordance with the above principles.
5.2.2. Application Process:
5.2.2.1. Issuing the contract for the Client
Upon notification of the acceptance of the proposal by the client to the Planning Responsible
by e-mail, the UDFRM.07 M Medical Devices Product Certification Contract which
includes the legal responsibilities, commitments and compensation as well as the
confidentiality requirements for the manufacturer and UDEM ADRIATIC D.O.O., is prepared
by the Planning Responsible based on the information in the UDFRM.179 MDR Offer Form
and FRM.82-2 Pre-Application Review Form. UDFRM.06-01 MDR Cover Letter of
Offer/Contract is prepared and these forms are submitted to the customer together by E-
mail. The UDFRM.07 M Medical Devices Product Certification Contract shall be issued in
two copies and signed by the manufacturer's authority and the official validity of the
signatory shall be requested to be sent to UDEM ADRIATIC D.O.O. together with a copy of the
Trade Registry Gazette or equivalent official document which shows the official formation of
the manufacturer. UDFRM.07 M Medical Devices Product Certification Contract shall be
UDEM Adriatic d.o.o
UDPD.04/ 06-03.06.2020/04.01.2018/Page:7/49
valid if signed mutually. A copy of the UDFRM.07.M Medical Devices Product Certification
Contract shall be put in the customer's file by the Planning Responsible, and the other copy
is sent to the Customer by the Planning Responsible via shipment.
After this stage, to start the certification process, the Planning Responsible asks the
manufacturer to send the following information and documents via e-mail or uploading to
the UDEM ADRIATIC D.O.O.’s server:
 Technical Documentation set out in Annex II and III of MDR

 System documentation of the organization (Manual, Procedures)
 a draft of an EU declaration of conformity in accordance with Article 19 and Annex IV
of MDR for the device model covered by the conformity assessment procedure,
 the documentation on the manufacturer's quality management system,
 a documented description of the procedures in place to fulfil the obligations arising
from the quality management system and required under MDR and the undertaking by the
manufacturer in question to apply those procedures,
 a description of the procedures in place to ensure that the quality management
system remains adequate and effective, and the undertaking by the manufacturer to apply
those procedures,
 the documentation on the manufacturer's post-market surveillance system and,
where applicable, on the PMCF plan, and the procedures put in place to ensure compliance
with the obligations resulting from the provisions on vigilance set out in Articles 87 to 92 of
MDR,
 a description of the procedures in place to keep up to date the post-market
surveillance system, and, where applicable, the PMCF plan, and the procedures ensuring
compliance with the obligations resulting from the provisions on vigilance set out in Articles
87 to 92 of MDR, as well as the undertaking by the manufacturer to apply those procedures,
 documentation on the clinical evaluation plan, and
 a description of the procedures in place to keep up to date the clinical evaluation plan,
taking into account the state of the art.
 A copy of the EU Quality Management system certificate or EU technical
documentation assessment certificate for the application of Annex IX (I) or Annex IX (II), if
any
 A copy of the EU type-examination certificates referred to in Section 4 of Annex X of
MDR for the application of Annex XI (Part A), except the Class II-a devices
 Identity documents (brochures, catalogues, promotional CDs, etc.)
 Certificate of Activity,
 List of authorized signatures belonging to the authority signing the contract,
 Copy of Trade Registry Gazette,
 Tax Certificate
 Bank receipt or payment receipt verifying that certification fee, which is defined in
the contract, has been paid.
5.2.2.2. Nomination of the Project Leader
In UDEM ADRIATIC D.O.O., Project Leader is appointed for every individual application. The
project leader is responsible for ensuring that the assessment of an individual application is
UDEM Adriatic d.o.o
UDPD.04/ 06-03.06.2020/04.01.2018/Page:8/49
conducted properly, observing the UDEM ADRIATIC D.O.O.'s procedures (in accordance with
the relevant legislation, guidance documents, CS and/or harmonised standards). This person
will ensure that the appropriate resources are utilised for each of the tasks of the
assessment. The project leader may be MDTRR. The project leader is assigned for each
application by the proposal of MDTRR by General Manager with UDFRM.206 Project
Leader Assignment Form, after the process which is described in 5.2.2.1 of this
procedure.
5.2.2.3. Application Review process
Project Leader is responsible for the application review process. All documents, which are
sent by the client and issued by UDEM ADRIATIC d.o.o. until to this stage, shall be submitted
to the Project Leader. During the review of the application made under the Medical Device
Regulation, Project Leader shall;
 First, check whether the product(s) within the scope of the application is a medical
device in the scope of MDR or not; in accordance with UDTLM.19 Medical Device
Classification Instruction.
 Check whether the related application is within the scope of the UDEM ADRIATIC
D.O.O.
 Determine the MDR and/or MDS and MDT codes for the applied device(s). In order to
determine the MDR and/or MDS and MDT codes Project Leader shall follow the
hierarchical orders of the codes. In order to do so s/he shall review all codes from top
to the bottom. If any active device does not fit in any code, which is listed above MDA
0318 “Other active non-implantable devices”, then the code of the device is
determined as MDA 0318. The same logic also applies for non-active non-implantable
devices, in that case the code is MDN 1214 “General non-active non-implantable
devices used in health care and other non-active non-implantable devices”
 Check the completeness of the application with respect to the requirements of the
relevant conformity assessment procedure, as referred to in the corresponding Annex
of MDR, under which approval has been sought,
 Verify the respective classifications of the applied product(s) in accordance with

UDTLM. 19 Medical Device Classification Instruction.
 Check the of appropriate conformity assessment route is provided as specified in

5.2.1.2. (S/he shall record the result of her/his evaluation on FRM.82 Application
Review Form)
 Check the availability of sufficient and appropriate resources
 Review the outsourced production processes specified by the manufacturer in the

FRM.81 Medical Devices Certification Application Form/other submitted
documentation. However, if any other site is required to be assessed by the Audit
team during both the preliminary examination and the Site Audit, the relevant
situation shall be carried out according to the UDTLM.52 MDR-Instruction for
Supplier -Subcontractor Assessment.
UDEM Adriatic d.o.o
UDPD.04/ 06-03.06.2020/04.01.2018/Page:9/49
 Review the presence of sterile barrier systems and the sterilization method
 Review, if it is a pre-certified product, certificate and validity of previous notified

body.
 Within the scope of the application and in accordance with UDEM ADRIATIC D.O.O.,
conformity assessment language is controlled.
 Technical standards and CS(s) regarding the product are checked with the presence
of ISO 13485 QMS certificate.
 Whether the relevant medical device is covered by another legislation is checked.
 If sampling of the technical documentation will apply, s/he shall determine the
number of technical documentations to be sampled according to the UDTLM.50
MDR-Technical Documentation Assessment Instruction.
 By checking the number of employees, the audit period is calculated with TLM 04-1
MDR-Product Certification Audit Duration Determination Instruction both for
initial certification, surveillance and recertification.
 The requirement for the consultation according Section 5 of Annex IX of MDR is

reviewed by the Project Leader according to UDPD.18 MDR Annex IX Conformity
Assessment Procedure.
All records related to this stage are transferred to the FRM.82-1 MDR Application Review
Form by Project Leader.
After the application review, if Project Leader determines any missing information, then
s/he shall request this information from the client via Planning Responsible same as
explained above. In this stage s/he also may request any additional information to complete
the application review process.
If the project leader determines that the product is not a medical device under MDR, then
s/he shall consult to any product reviewer who has assigned with the relevant MDR/MDS
code via E-mail.
Refusals or withdrawals of the applications in this stage shall be recorded by the Project
Leader in FRM.82-1 MDR Application Review Form and MDTRR shall be notified by
him/her.
MDTRR is responsible to notify about the refusals or withdrawals of the applications via
electronic system referred in Article 57 of MDR, according to the UDPD.10 NOTIFICATION
PROCEDURE.
UDEM Adriatic d.o.o

UDPD.04/ 06-03.06.2020/04.01.2018/Page:10/49
6. AUDIT PLANNING PROCESS:
6.1 Appointment of Project Leader
In UDEM ADRIATIC D.O.O., Project Leader is appointed for every individual application. The
project leader is responsible for ensuring that the assessment of an individual application is
conducted properly, observing the UDEM ADRIATIC D.O.O.'s procedures (in accordance with
the relevant legislation, guidance documents, CS and/or harmonised standards). This person
will ensure that the appropriate resources are utilized for each of the tasks of the
assessment. The project leader can be MDTRR. The project leader is assigned for each
application by the proposal of MDTRR by General Manager with UDFRM.206 Project
Leader Assignment Form.
If the project leader is not MDTRR, then he/she will review all the processes (pre-application
review and contractual requirements) from application to his/her appointment to ensure
that all procedures are applied correct, complete and efficient. His/her responsibility begins
with the application review, then s/he manages all the processes from the planning to the
certification committee and reviews all records and submitting documentation before the
final review process of the Committee. S/he is responsible also managing the planning
responsible in order to ensure effective communication with the client.
6.2 General principals of the appointment of Personnel in different conformity

assessment tasks
All codes (MDR/MDS/MDT) of each application are determined during the application
review process. As explained detailed in section 5.2.2.3., in order to determine the MDR
and/or MDS and MDT codes Project Leader shall follow the hierarchical orders of the codes.
In order to do so s/he shall review all codes from top to the bottom. If any active device does
not fit in any code, which is listed above MDA 0318 “Other active non-implantable devices”,
then the code of the device in the application is determined as MDA 0318. The same logic
also applies for non-active non-implantable devices, in that case the code is MDN 1214
“General non-active non-implantable devices used in health care and other non-active non-
implantable devices”. After this process, the personnel from the UDLST.07 MDR
Conformity Assessment Personnel Matrix shall be appointed by the project leader for the
review of the technical documentation and site audits according to the principals explained
below.
For the technical documentation review, the product reviewer(s), who is/are responsible to
review the technical documentation, both in preliminary and Stage 2, has/have all the
relevant MDR and the horizontal MDS code(s).
For all on-site assessments, QMS Stage 1, QMS stage 2, surveillance and unannounced audits,
audits in manufacturer’s supplier(s) and/or subcontractor(s), shall be conducted by an audit
team that consists of site auditor(s) and at least one of the site auditors with the necessary
MDT code. If the manufacturing technology requires more than one MDT code, then the
audit team shall consist member(s) with all MDT codes. The site auditor, who has the MDT
code, shall assess all articles related with the technology of the device and this shall be
UDEM Adriatic d.o.o
UDPD.04/ 06-03.06.2020/04.01.2018/Page:11/49
showed in the CE marking Site Audit plan. The other site auditor(s) may review the articles
which are not related with the technology of the product. (for example; control of
documents, control of records etc.)
For the clinical evaluation, a clinical expert with a relevant MDR code, shall be assigned by
the internal clinician with the coordination of the project leader in order to assess the
clinical evaluation documentation of the manufacturer.
For the certification committee, at least one member of the committee shall have the MDR
and the horizontal MDS and MDT codes to conduct the final review and decision-making
process.
6.3 Appointment of Audit Team (Site Auditor(s))/Product Reviewers/Clinical Experts
Project Leader is responsible for the appointment of the audit team/product reviewers and
in coordination with the internal clinician the clinical experts. In order to clarify the
relationship between the client and themselves, people involved in the conformity
assessment procedures, are asked to sign the MFRM.06-1 Auditor Declaration Form
before both the technical documentation and quality management system assessment.
Clinical experts who will take part in the conformity assessment stages are asked to sign the
MFRM.06-2 MDR Clinical Expert Impartiality Declaration form.
The planning Responsible sends FRM.55 Auditor Information Forms, which contain brief
information about the members of the audit team, to the customer at least 2 days prior to
the QMS Site Audits (except for unannounced Site Audits) and receives confirmation. The
customer has the right to object to the inclusion of particular members on the audit team on
reasonable grounds. In such a case, the new team is determined.
6.4. Planning of QMS Preliminary Review Process
The planning stage of the QMS Preliminary Review Process can be carried out in two ways
by the UDEM ADRIATIC D.O.O. If the manufacturer has an accredited ISO 13485:2016
certificate or EC/EU Certificates according to MDD/MDR, then the auditor(s), review the
QMS documentation on desk.
At this situation, Project Leader choose a site auditor or group of site auditors, who have the
necessary MDT code(s) for the specified medical device technology, by taking into account
the information on FRM 82-1 MDR Application Review Form from the UDLST.07 MDR
Conformity Assessment Personnel Matrix for the QMS preliminary review.
The audit duration is determined by the Project Leader according to TLM 04-1 MDR-
Product Certification Audit Duration Determination Instruction.
The QMS documentation, which is submitted by the manufacturer with the application, is
sent by the planning Responsible to relevant auditor(s) via e-mail or from the UDEM Adriatic
software and if not feasible, a copy of it via shipping. The auditor(s) are informed of the
deadline for delivering the preliminary examination report via e-mail or UDEM Adriatic
UDEM Adriatic d.o.o
UDPD.04/ 06-03.06.2020/04.01.2018/Page:12/49
Software by the planning Responsible. The auditors are reviewed the QMS documentation
according to UDPD.18 MDR Annex IX Conformity Assessment Procedure or UDPD.19
MDR Annex XI PART A Conformity Assessment Procedure according to the type of the
application.
If the manufacturer does not have an accredited ISO 13485:2016 certificate or EC/EU
Certificates according to MDD/MDR, then the audit team, review the QMS documentation on
the manufacturer's premises and, if appropriate, on the premises of the manufacturer's
suppliers and/or subcontractors to verify the manufacturing and other relevant processes.
At this situation, Project Leader chooses an audit team, who have the necessary MDT code(s)
for the specified medical device technology, by taking into account the information on FRM
82-1-MDR Application Review Form from the UDLST.07 MDR Conformity Assessment
Personnel Matrix for the QMS preliminary review.
One of the auditors with relevant qualification is assigned as lead auditor. If the audit team is
consisted of one auditor, then this auditor with relevant qualification is assigned as lead
auditor.
The QMS documentation, which is submitted by the manufacturer with the application, is
sent by the planning Responsible to the lead auditor via e-mail or via UDEM Adriatic
Software and if not feasible, a copy of it via shipping.
The Planning Responsible informs the customer about the draft date determined in the audit
schedule via e-mail and upon receiving approval from the customer, arranges
accommodation, transportation etc. for the audit team.
The lead auditor is responsible to prepare a site audit plan with the form UDFRM.22.02 CE
Marking Site Audit Plan. In this plan, s/he has to define the time intervals with the
requirements, which will review during the on-site audit. The lead auditor has to send the
UDFRM.22.02 CE Marking Site Audit Plan to the planning responsible at least three days
prior of the on-site audit, which is sent to the client for the approval.
The audit, which is carried out in the manufacturer's suppliers and/or subcontractors, is
carried out according to UDTLM.52 Instruction for Supplier -Subcontractor Assessment.
The audit is conducted according to UDPD.18 MDR Annex IX Conformity Assessment

Procedure or UDPD.19 MDR Annex XI PART A Conformity Assessment Procedure
according to the type of the application.
6.5. Planning of QMS Site Audits
Project Leader choose an audit team, which consist of site auditors and at least one member
of the audit team shall have the necessary MDT code(s) for the specified medical device
UDEM Adriatic d.o.o
UDPD.04/ 06-03.06.2020/04.01.2018/Page:13/49
technology, by taking into account the information on FRM 82-1-MDR Application Review
Form and the result of the QMS Preliminary Review from the UDLST.07 MDR Conformity
Assessment Personnel Matrix for the QMS Site Audits. Audit team members are asked to
sign the MFRM.06-Auditor Statement in order to clarify the relationship between them and
the client to be audited. Planning Responsible sends FRM.55.-Auditor Information Form
that contains brief information about the audit team members to the client at least 2 days
before the audit and receives confirmation. Provided that the client shows reasonable
grounds, he/she has the right of objection to the audit team. In this case, a new team shall be
designated.
One of the auditors with relevant qualification is assigned as lead auditor. If the audit team is
consisted of one auditor, then this auditor with relevant qualification is assigned as lead
auditor.
The QMS documentation, which is submitted by the manufacturer with the application, and
the review report is sent by the planning Responsible to the lead auditor via e-mail or via
UDEM Adriatic Software and if not feasible, a copy of it via shipping.
The audit, which is carried out in the manufacturer's suppliers and/or subcontractors, are

After the audit, the lead auditor has to fill the relevant parts of FRM.121-1 MDR-QMS Audit
Programme Form in order to give feed back to the auditors, which will be assigned for the
next audits.
6.6. Planning of Preliminary Technical Documentation Assessment:
Project Leader shall choose the product reviewer(s), who have the necessary MDR/MDS
code(s) for the medical device in question, by taking into account the information on FRM
UDEM Adriatic d.o.o

UDPD.04/ 06-03.06.2020/04.01.2018/Page:14/49
82-1 MDR Application Review Form from the UDLST.07 MDR Conformity Assessment
Personnel Matrix for the Preliminary Technical Documentation Assessment.
The assessment duration is determined by the Project Leader according to TLM 04-1 MDR-
The Technical Documentation, which is submitted by the manufacturer with the application
is sent by the planning Responsible to the product reviewer(s) via e-mail or via UDEM
Adriatic Software and if not feasible, a copy of it via shipping. The product reviewer(s) are
informed of the deadline for delivering the preliminary examination report via e-mail by the
planning Responsible.
The auditors review the technical documentation according to UDPD.18 MDR Annex IX
Conformity Assessment Procedure or UDPD.19 MDR Annex XI PART A Conformity
Assessment Procedure according to the type of the application.
6.7. Planning of Technical Documentation Assessment:
Project Leader choose product reviewer(s), who have the necessary MDR/MDS code(s) for
the medical device in question, by taking into account the information on FRM 82-1 MDR
Application Review Form and the result of the Technical Documentation Preliminary
Review from the UDLST.07 MDR Conformity Assessment Personnel Matrix for the
Technical Documentation Assessment
UDEM ADRIATIC D.O.O. can conduct the technical documentation assessment in the office or
on the manufacturer site dependent on the following conditions. If the technical
documentation is assessed on-site, then this assessment is accompanied with the QMS audit.
If the product reviewer(s), who have the particular MDR/MDS code for the assessed device,
can attend QMS on site audit, then the technical documentation review can be conducted on
site. However, if the product reviewers on site do not have all the necessary MDR/MDS
codes, then some parts of the technical documentation review could be conducted on site
and the other parts in the office. For example, for the conformity assessment of an active
medical device; if the product reviewer that attends the QMS audit has the MDR code for the
assessed device; but does not have the MDS code for the software, then the review of the
documents related to the software shall be conducted in the office. If the Stage 2 QMS on site
audit is conducted by auditors, who have the necessary MDT codes but do not have the
MDR/MDS codes; then the whole technical documentation review shall be conducted in the
office. In this case, the technical documentation review has to be conducted prior to stage 2
QMS audit, so that product reviewer(s) could give their advice to the on-site audit team
leader on aspects of the manufacturer’s design or production processes which could be of
particular relevance for the on-site audit. UDFRM.22.02 CE Marking Audit Plan should
clearly indicate the dedicated sections to be reviewed by each auditor and product
reviewers, including on-site and office reviews.
Product reviewers are asked to sign the MFRM.06-1 MDR Auditor Declaration in order to
clarify the relationship between them and the client to be audited. If the technical
UDEM Adriatic d.o.o
UDPD.04/ 06-03.06.2020/04.01.2018/Page:15/49
documentation assessment is accompanied with the QMS site Audit, then planning
Responsible sends FRM.55. Auditor Information Form that contains brief information
about the audit team members to the client at least 2 days before the audit and receives
confirmation. Provided that the client shows reasonable grounds, he/she has the right of
objection to the audit team. In this case, a new team shall be designated. When both QMS
and Technical Documentation are assessed within same site audit an audit team that covers
all of MDA/N/T/S codes related with the medical devices / technologies is organized.
Technical documentation review can be performed on desk or on-site. When it is organized

on desk, the technical documentation, which is submitted by the manufacturer with the
application, and the review report is sent by the planning Responsible to the product
reviewer via e-mail or via UDEM Adriatic Software and if not feasible, a copy of it via
shipping.
When it is organized on site, the Planning Responsible informs the customer about the draft
date determined in the audit schedule via e-mail and upon receiving approval from the
customer, arranges accommodation, transportation etc. for the audit team.
The assessment is conducted according to UDPD.18 MDR Annex IX Conformity

Assessment Procedure or UDPD.19 MDR Annex XI PART A Conformity Assessment
Procedure according to the type of the application.
7. INITIAL CERTIFICATION PROCESS:
7.1. Preliminary Assessment of QMS and Technical Documentation
During initial certification process QMS documentation and Technical Documentation is

reviewed on desk / on site with using UDFRM.32-1 MDR QMS Preliminary Audit Report
and UDFRM.32 Technical Documentation Pre-Review Report according to UDPD.18
MDR Annex IX Conformity Assessment Procedure or UDPD.19 MDR Annex XI PART A
Conformity Assessment Procedure depending on the type of the application.
Technical documentation examination has been explained in the UDTLM.50 Technical

Documentation Assessment Instruction, UDPD.18 MDR Annex IX Conformity
Procedure.
UDEM Adriatic d.o.o

UDPD.04/ 06-03.06.2020/04.01.2018/Page:16/49
If it is confirmed during the QMS / Technical documentation examination that conditions of

relevant procedure have been fulfilled, On-Site QMS / Technical Documentation Assessment
planning can be initiated. The time gap between the preliminary examination and on-site
audits is reasonably supposed to be not more than 6 months. At the end of the six-month
period, it is decided whether the additional investigation or on-site audit should be carried
out or not in accordance with the success of the non-compliance closing activities and the
process change information. If there is no change in production process, this period can be
increased.
Major nonconformities or uncertainties detected during the preliminary examination

constitute an obstacle to the fulfilment of On-Site Audit. Therefore, it is impossible to
proceed with the On-Site Audit without closing these nonconformities. The personnel who
conducted the QMS/ Technical Documentation review declare their view and advice to
continue with the On-Site Audit, or not.
7.2. Clinical Evaluation
The clinical evaluation documentation prepared by the manufacturer is reviewed by the

clinical expert appointed in the relevant MDR code on desk according to UDPD.17 Clinical
Evaluation Procedure. Findings are recorded by UDFRM.85 MDR Clinical Evaluation
Report. The clinical evaluation assessment reports prepared by the clinical expert are
reviewed by internal clinician and then sent to manufacturer via email or via UDEM Adriatic
Software by Planning Responsible before the site Audit if possible and if non-conformity has
been identified, the manufacturer is expected to provide corrective actions. The clinical
evaluation file revised after corrective action is re-evaluated by the relevant Clinical Expert
according to the above principles.
7.3. Software Review
If the manufacturer's medical device contains software, the product reviewer assigned in the
code MDS1009 reviews the validation file. The review can be carried on desk or on site. The
findings of the assessments are recorded in UDFRM.84-03 MDR Software Technical
Documentation Assessment Form and UDFRM.84-04 MDR Software Cybersecurity
Requirements Checklist. The report is delivered to the manufacturer via email or via
UDEM Adriatic Software by Planning Responsible and the manufacturer is expected to
provide corrective preventive action, if any non-conformity is detected during this review.
7.4. Medicinal and Absorbable Product Review
In case the manufacturer's medical device contains ancillary medicinal substance or and
absorbable substance, the product reviewer assigned in the code MDS1001/1008 reviews
the manufacturer's technical documentation in relation to the medicinal product and
absorbable substance. This assessment is carried out on the medicinal product are specified
within the scope of the UDPD.20 MDR-Procedure for Examination of Medical Devices
UDEM Adriatic d.o.o

UDPD.04/ 06-03.06.2020/04.01.2018/Page:17/49
Incorporating Medicinal Substance or Substances Absorbed by Human Body. The

review can be carried out in the office or on the Site. The findings of the examination are
recorded in the UDFRM.84-01 Technical Documentation Review for Medical Devices
Containing Medicinal Products and UDFRM.33 MDR Certification Audit Report form.
The report is delivered to the manufacturer via email or via UDEM Adriatic Software by
Planning Responsible and the manufacturer is expected to provide corrective preventive
action, if any non-conformity is detected during this review. After the conformity assessment
processes of these devices have been completed in UDEM ADRIATIC D.O.O., the file will be
sent to one of one of the competent authorities designated by the Member States in
accordance with Directive 2001/83/EC for example HALMED or the EMA. In case of positive
scientific opinion, certification process is performed and in case of negative result, the
related application is refused.
7.5 QMS and Technical Documentation Assessments
Issues related to QMS / Technical Documentation assessment are described in UDTLM.50

Technical Documentation Assessment Instruction, UDPD.18 MDR Annex IX Conformity
Procedure.
The assessment time is determined according to the TLM 04-1 MDR-Product Certification
Audit Duration Determination Instruction by the Project Leader.
QMS and Technical documentation reviews are performed with UDFRM.33-1 MDR
QMS Audit Report and UDFRM.33 MDR Certification Audit Report, respectively by the
relevant site auditors and product reviewers.
The assessment reports of UDEM ADRIATIC D.O.O. include the following;
— clearly document the outcome of its assessment and draw clear conclusions from the
verification of the manufacturer's conformity with the requirements of MDR 2017/745/EU.
— make a recommendation for a final review and for a final decision to be taken by the
notified body; this recommendation shall be signed off by the member of personnel
responsible in the notified body, and
All of the audit reports are provided to manufacturer during or after the assessments.
The nonconformities determined by the audit team as a result of the audit commencing with
the opening meeting shall be mutually approved with using UDFRM.164 MDR
OBSERVATION AND NON-CONFORMITY REPORT. The following forms are used for
assessments:
DOCUMENTS:
MFRM.06-1 MDR Auditor Declaration Form
FRM.55 Audit Team Information Form
MFRM.27 CE Marking Audit Meeting Minutes Form
UDFRM.22.02 CE Marking Site Audit Plan
UDEM Adriatic d.o.o

UDPD.04/ 06-03.06.2020/04.01.2018/Page:18/49
UDFRM.121-1 MDR QMS Audit Program

UDFRM.178 MDR Audit Programme Form
UDFRM.32 MDR Technical Documentation Pre-review Report (Class I measuring function)
UDFRM.32 MDR Preliminary Audit Report
UDFRM.33 MDR Certification Audit Report
UDFRM.33-1 MDR QMS Audit Report
MFRM.164 MDR Observation and Non-conformity Form
UDFRM.84-01 Technical Documentation Review for Medical Devices Containing Medical
Products (if necessary)
UDFRM.84-02 Active Medical Device Technical Documentation Examination Form (if
necessary)
UDFRM.84-03 MDR Software Technical Documentation Assessment Form
UDFRM.84-04 MDR Software Cyrbersecurity Requirements Checklist
MFRM.06-2 Clinical Expert Impartiality Declaration
UDFRM.85 Clinical Evaluation Assessment Report (if necessary)
UDFRM.157 Medical Device Sampling Report (if necessary)
UDFRM.83.M Draft Certificate
7.5.1 Communication during the on-site audits
In case the evidences emerged during the audit constitute that the audit cannot reach the
objectives or entail a medium or high risk (security etc.), lead auditor will report this
situation to the client and if possible to UDEM ADRIATIC D.O.O. In such case, it can be
required to reapprove the audit plan by changing and also to change the audit objectives,
scope or audit process or termination of the audit. At the same time, the lead auditor has to
report the activity plan results which UDEM ADRIATIC D.O.O. will take.
During the site audit, the audit team controls the number of customer employees. If there is
a difference between the number of employees declared at the time of the application and
the number of employees identified on the scene, the Lead Auditor should immediately
communicate the situation to the Project Leader. If the Project Leader decides to increase
the number of days, the audit plan may need to be changed and re-approved, the audit
period or the result (TERMINATION) changed.
The lead auditor reviews the changes which emerged during the site audit and were
recommended by the client in the activity field and also inform the project leader. If
necessary, the lead auditor assesses the audit improvement periodically together with the
audit team and provide the information interchange. If necessary, the lead auditor assesses
the client’s problems and also the audit improvement by communicating with the client
periodically. Prior to the closing meeting, the audit team shall review the audit findings, and
any other appropriate information obtained during the audit, against the audit objectives
and audit criteria and classify the nonconformities.
UDEM Adriatic d.o.o

UDPD.04/ 06-03.06.2020/04.01.2018/Page:19/49
7.5.2 Observers and Company Representatives in on-site audits:

 During the audit, the observers approved by UDEM ADRIATIC D.O.O., can be involved in
the audit. The audit team provide that the observers don’t affect the audit or don’t
intervene in the audit process or results. These observers can be the client
representatives, consultants, personnel, translators who carry out the witness audit of the
accreditation body/designating authority.
 The lead auditor provides that the company representatives guide only and that they don’t
intervene in the audit and its results.
 FRM.55 Audit Team Information Form and UDFRM.22.02 CE Marking Site Audit Plan
are sent to the customer at least 2 days in advance and they are approved. It is ensured by
the lead auditor that the company representatives do not interfere with the results of the
guidance and its conclusions.
7.5.3 Assessment of nonconformities and CPAs:

7.5.3.1 Classification of the audit findings:
Findings of the audit team may involve major and minor nonconformities, which are
classified by the audit team with the following principles.
It is essential that nonconformities are clearly worded with factual and precise language that
enables the reader to comprehend the actual non-fulfillment that was detected during the
audit. The information presented should be an accurate representation of the reviewed
records, samples and procedures, as well as interviews conducted.
For the classification of the nonconformities, the auditor shall assess the influence of the
nonconformity to the safety and performance of the medical device. If there is an indirect
influence of the nonconformity to the safety and performance of the device, this an indirect
impact. If there is a direct influence of the nonconformity to the safety and performance of
the device, this a direct impact. When classifying the non-conformities, first the auditor shall
classify the non-conformity as direct impact or in direct impact.
Minor: Minor non-conformities are a single lapse in the fulfillment of a requirement, which
has an indirect influence on the safety and performance of the device (indirect impact). If
there is an absence of the documentation for a requirement, the nonconformity can not be
classified as minor since the absence of a documented process or procedure will
fundamentally affect consistency and effective implementation of any process. A
nonconformity which resulted in the release of a nonconforming medical device to the
market shall never be classified as a minor non-conformity.
Major: Major non-conformites are non-conformities that have a direct impact. Major non
conformity is described as one of the following: 1) “a total absence in the fulfillment of a
requirement,” 2) “repetition of a previous nonconformity,” 3) “failure to address a
previously identified minor non-conformity” 4) “release of non-conforming product.”. The
absence of the documented processes or procedures shall be yield as major nonconformities.
UDEM Adriatic d.o.o

UDPD.04/ 06-03.06.2020/04.01.2018/Page:20/49
7.5.3.2 Assesment of the nonconformities and CPAs:

In order to make a decision regarding certification, the client needs to report to our
organization the CPAs that will eliminate nonconformities and the auditor must make sure
that implementation of these CPAs is sufficient to put an end to nonconformities. For this
reason, the client primarily needs to carry out a root cause analysis in order to investigate
the reasons without considering whether the nonconformities are major or minor. And
according to this analysis he or she needs to specify corrections or CPAs to be done and draw
up a plan. In general, a period of 15 days is given to the client so that it reports the
correction or corrective and preventive action plan to be applied for eliminating the
nonconformities. On the other hand, the time given so that it reports to our organization-by
informing the lead auditor of the audit team- the evidence about the implementation of these
activities is maximum 3 months as of the end of audit for both minor and major non
conformities. The time allowed for customer corrective actions is specified at the end of the
UDFRM.164 Mdr Observation and Non-Conformity Report and thus is notified to the
customer. While minor non conformities do not need a follow up on-site audit, some major
non conformities which cannot be closed by document review are addressed with an on-site
follow-up audit decision of lead auditor. Those that do not require a follow-up audit are
assessed based on the CPA plans regarding the corrective actions and the objective evidence.
When a follow-up audit is required, no decisions related to certification are made before the
audit has been completed. If the objective evidence of corrective actions from the client is
found insufficient by the audit team, the organization is notified in writing and additional
work is requested. This period can not exceed 6 months in any way. If the manufacturer can
not close major/minor nonconformities within 6 months, the on site audit is repeated.
7.5.3.3 Follow-up Audits

In the Initial Certification Audit; the period of time required for the notification of the
objective evidence of the implementation of the activities and the follow-up audit to be
carried out is 6 months at the latest. If the nonconformities are not closed or new non-
conformities are observed during the follow-up audit, or if the applied corrective actions are
not found effective by the lead auditor, the application of the customer is suspended and a
follow-up audit is carried out after 3 months. If it is found that the nonconformities have not
been remedied in this follow-up audit, the application is refused. The refusal of the
application shall be notified according to NOTIFICATION Procedure. The lead auditor
specifies the recommendation to certify that the corrective actions can be verified based on
objective evidence based on sufficient and effective implementation by writing in the on site
audit report and sends the audit file to the Planning Responsible. If the UDEM ADRIATIC
D.O.O. is unable to verify corrective actions and the implementation of corrective actions
within 6 months of the on site audit, it may be necessary to carry out another on site audit.
UDEM Adriatic d.o.o

UDPD.04/ 06-03.06.2020/04.01.2018/Page:21/49
7.6 General review
7.6.1. General Review of the Planning Responsible
Planning Responsible checks, the client file to be submitted to the certification committee
Project Leader with UDFRM.106 MDR Control List of Audit Set, signs the form and submits
it completely to the the project leader.
7.6.2 Review of the Project Leader
Project Leader is responsible for ensuring that the assessment of an individual application is
conducted properly, observing the UDEM ADRIATIC's procedures (in accordance with the
relevant legislation, guidance documents, CS and/or harmonised standards). The Lead
Auditor of the QMS-audit and the product reviewer(s) who conducted the technical
documentation assessment, and the internal clinician submit all records related to the
conformity assessment procedures and the latest technical and QMS documentation of the
manufacturer to the Project Leader. S/he checks the completeness of all records and
documentation for the final-review. In particular, s/he shall review the whole conformity
assessment records and the QMS and technical documentation of the manufacturer to be
sure that the documentation in which if any, the corrections of the nonconformites are
applied and that those documentations are at the latest revision as well as the conflict of
interest analysis of the QMR with UDFRM.215 MDR Documentation Control Form. If there
is a missing record, s/he shall ask the missing records to the related assessor. After this
process, s/he shall submit all files to the Certification Committee.
8. DECISION OF CERTIFICATION
The Product Certification Committee is responsible for the final review and decision making.
The final review and decision-making are conducted by the internal personnel of UDEM
ADRIATIC D.O.O. The internal clinician is always a member of the committee with regard to
clinical aspects. The members of the product certification committee are different than the
personnel who have conducted the assessments. The project leader of the assessed
application shall not be a member of the Certification Committee.
The member(s) of the product certification committee other than the internal clinician are
selected from the UDLST.07 MDR Conformity Assessment Personnel Matrix by Medical
Device Technical Regulatory Responsible. At least one member of the product certification
committee has to have product specific knowledge according to the following principles.
For the final review and decision-making process, the knowledge and expertise of the
committee member should cover a broader base. Therefore, the internal personnel, who has
any active medical device MDR code as a product reviewer and a horizontal MDT code for
the device technology as a site auditor, can be assigned as a member in the committee for the
UDEM Adriatic d.o.o
UDPD.04/ 06-03.06.2020/04.01.2018/Page:22/49
final-review and decision-making of all active medical devices. Same as, the internal
personnel, who has any non-active medical device MDR code and a horizontal MDT code for
the device technology, can be assigned as a member in the committee for the final-review
and decision-making of all non-active medical devices.
For non-active medical devices, the internal personnel can be assigned as a member in the
committee for the final-review and decision-making, if s/he has main group MDR code(s)
(1100, 1200) as a product reviewer and the horizontal MDT code for device technology as a
site auditor. For example, the final-review and the decision-making for a device with the
MDN 1202 code; can be performed by a product reviewer; who has any of the 1200 group
codes.
The qualification crieteria and the assigning of the personnel to the role of final reviewer and
decision maker is explained in MPD.03 MDR Conformity Assessment Personnel
Assigning Procedure. The conformity assessment personnel who have the desired
qualification are shown in UDLST.07 MDR Conformity Assessment Personnel Matrix.
8.1 Final Review Process
After the process described in the section 7.6.2, the members of the committee review all the
records and the technical and QMS documentation of the manufacturer and verify that the
report or reports and supporting documentation needed for decision making, including
concerning resolution of non-conformities noted during assessment, are complete and
sufficient with respect to the scope of the application, and verify whether there are any
unresolved non-conformities preventing issuance of a certificate. At this stage MFRM.09-3
MDR Technical Review Question is used by the members of committee.
The final-review results are recorded on the FRM.28-1 MDR Certification Committee
Report. The members of the certification committee may ask additional information,
documents and/or additional assessments. If so, the review report is submitted to the
Project Leader. S/he notifies the manufacturer for the additional information, documents,
which are requested by the Product Certification Committee.
If there is no need to have additional information, then the members of the certification
committee will continue to the decision-making process.
8.2. Decision-making Process
The Product Certification Committee gives all decisions on the activities of the UDEM
ADRIATIC D.O.O. during the certification process.
The Product Certification Committee will not issue a certification decision without ensuring
that all identified minor and major nonconformities have been completely closed. When
initial certification and re-certification decision are given, the certificate of customer is valid
for the period it indicates from the registration of the certificate. The validity of the
UDEM Adriatic d.o.o

UDPD.04/ 06-03.06.2020/04.01.2018/Page:23/49
certificates cannot be exceeding 3 years for Class III devices, 4 years for IIb implantable
devices, 3 years for the Novalty devices; 5 years for other devices.
The decision regarding to the application is recorded on the MFRM.12-1 MDR Committee
Decison Report and the report is signed by every member of the certification committee,
who has the desired qualification to be a decision-maker.
UDEM ADRIATIC D.O.O. Certification Committee shall
a. decide, based on the assessment documentation and additional information available,

whether the requirements of Medical Device Regulation are fulfilled,
b. decide, based on the results of its assessment of the clinical evaluation and risk
management, whether the post-market surveillance plan, including the PMCF plan, is
adequate,
c. decide on specific milestones for further review by UDEM ADRIATIC D.O.O. of the up
to date clinical evaluation,
d. decide whether specific conditions or provisions need to be defined for the
certification,
e. decide, based on the novelty, risk classification, clinical evaluation and conclusions
from the risk analysis of the device, on a period of certification not exceeding
Class III devices: 3 years

Class IIb devices: 4 years
Novalty devices: 4 years
For Class IIa, Class I (Steril, measurement and reusable): 5 years
If the decision of the committee is to issue the certificate, then the certificate is issued
according to UDTLM.47 Medical Device Certificate Instruction.
The manufacturer is notified of the outcome of the assessment and the resultant decision
according to UDPD.10 MDR- Notifications Procedure, which has the information for the
enterance into the electronic system referred to in MDR Article 57.
8.3 Changes and Modifications
Changes and modifications regarding the documentation and / or processes assessed during
certification process is evaluated according to UDPD.18 MDR Annex IX Conformity
Assessment Procedure (planned changes regarding to QMS system in the section 6.2.4 and
planned changes regarding to approved device in the section 6.3.3) or UDPD.19 MDR
Annex XI PART A Conformity Assessment Procedure in the section 6.2.2.4. The customer
organization informs the UDEM ADRIATIC D.O.O. before making any changes to any of the
following:
— the approved quality management system or systems or to the product-range covered,

— the approved design of a device,
— the intended use of or claims made for the device,
— the approved type of a device, and
UDEM Adriatic d.o.o

UDPD.04/ 06-03.06.2020/04.01.2018/Page:24/49
— any substance incorporated in or utilised for the manufacturing of a device and being
subject to the specific procedures in accordance with MDR Section 4.5.6.
UDEM Adriatic d.o.o. ensures that the manufacturer notifies the planned changes to UDEM
Adriatic d.o.o. with the UDFRM.07.M Product Certification Contract, which is signed with
the manufacturer at the beginning of the conformity assessment.
Estimation of planned changes and assessment of the changes made, including the
verification of the significance of the change is given detailed in the abovementioned
procedures.
9. COMPLETION OF THE CERTIFICATION PROCESS
The project leader provides a copy of MFRM.12-1 MDR Committee Decison Report, which
contains certification scope and other necessary information, to the Administrative Financial
Affairs Responsible to ensure that the customer's payment information is checked and the
invoice is prepared. For the printing of the certificate, the company information and
UDFRM.83.M Draft Certificate is sent to the Certificate Printing Department. A copy of the
printed certificate is kept into the Customer file. The controls of the printed certificates are
made by the Medical Device Technical Regulation Responsible and Project Leader with
UDFRM.100 Certificate Control Form.
The general requirements and content of the certificates are given in UDTLM.47 Medical
Device Certificate Instruction.
10. SURVEILLANCE AUDIT PROCESS
Surveilance audits are performed for Class I, IIa, IIb and III devices according to UDPD.18
MDR Annex IX Conformity Assessment Procedure or UDPD.19 MDR Annex XI PART A
Conformity Assessment Procedure, which is relevant.
Planing Responsible reviews UDEM ADRIATIC D.O.O. Client Portal every month and
determines clients requiring surveillance audit. He or she gets in contact with the clients
requiring surveillance audit at least 3 months before the date the audits should be carried
out by sending them FRM.144-1 ISO 13485& MDR Surveillance/Recertification Audit
Information Form. The surveillance audits shall be carried out at least once in 12 months.
If UDEM Adriatic d.o.o. cannot conduct the surveillance audit in this time period by any
reason, then the certificate shall be suspended until the audit has been carried out by UDEM
Adriatic d.o.o.
If the client approves the surveillance audit date, authorized person of the company shall
approve, stamp and sign FRM.144-1 ISO 13485& MDR Surveillance/Recertification
UDEM Adriatic d.o.o

UDPD.04/ 06-03.06.2020/04.01.2018/Page:25/49
Audit Information Form and then send the form back to UDEM ADRIATIC D.O.O. Planning
Responsible submits a copy of the approved form to the Project leader of that client.
Project leader reviews the information in FRM.144-1 ISO 13485& MDR

Surveillance/Recertification Audit Information Form and UDFRM.121-1 MDR QMS
Audit Program, UDFRM.107 MDR Annual Technical Documentation Examination Plan
and UDFRM.178 MDR Technical Documentation and Site Sampling Plan. If the
surveillance is conducted for a Class II-a and Class II-b other than implantable and Class II-b
implantable devices which are sutures, staples, dental fillings, dental braces, tooth crowns,
screws, wedges, plates, wires, pins, clips and connectors, then the quality management
system assessment shall be accompanied by the assessment of technical documentation for
devices, which are programmed for this particular surveillance assessment. In that case, the
selected technical documentation according sampling plan for this surveillance period,
which is determined during the initial certification, according to the principles set out in
UDTLM.50 MDR-Technical Documentation Assessment Instruction, shall be assessed by
the qualified product reviewer(s) and clinical expert(s).
By reviewing the information on the abovementioned forms, the project leader assesses the
audit duration according to TLM 04-1 MDR-Product Certification Audit Duration
Determination Instruction.
The assessment of the technical documentation and the assignment of the product
reviewer(s) and clinical expert(s) is conducted with same method as the initial certification.
10.3.1 Surveillance audits in the QMS of the manufacturer
The surveillance audit is a periodical audit and does not require the all system to be audited.
Besides, surveillance audits should be planned in a way to complete each other (1st and 2nd
surveillances) in order to make certain whether the certified QMS meets, during the period
between the audits, requirements of the MDR Annex to which it is subject or not.
Project leader shall assign site auditor(s) for the surveillance assessment according to the
principles set out in section 6.4 of this procedure by taking in account that a lead auditor
shall neither lead nor attend audits for more than three consecutive years in respect of the
same manufacturer.
One of the auditors with relevant qualification is assigned as lead auditor. If the audit team
consists of one auditor, then this auditor with relevant qualification is assigned as lead
auditor.
The QMS documentation and FRM.144-1 ISO 13485& MDR Surveillance/Recertification

Audit Information Form and UDFRM.121-1 MDR QMS Audit Program, UDFRM.107 MDR
and UDFRM.178 MDR Technical Documentation and Site Sampling Plan, the last audit
reports are sent by the planning Responsible to the lead auditor via e-mail or via UDEM
Adriatic Software and if not feasible, a copy of it via shipping.
UDEM Adriatic d.o.o

UDPD.04/ 06-03.06.2020/04.01.2018/Page:26/49
If the assessment of the technical documentation is accompanied with the surveillance on-
site QMS audit, then as explained in section 6.6 of this procedure; the UDEM ADRIATIC
D.O.O. can conduct the technical documentation assessment in the office or on the
manufacturer site dependent on the following conditions. If the technical documentation is
assessed on-site, then this assessment is accompanied with the QMS audit.
and the other parts in the office.
If the QMS on site surveillance audit is conducted by auditors, who have the necessary MDT
codes but do not have the MDR/MDS codes; then the whole technical documentation review
shall be conducted in the office. In this case, the technical documentation review has to be
conducted prior to QMS surveillance audit, so that product reviewer(s) could give their
advice to the on-site audit team leader on aspects of the manufacturer’s design or
production processes which could be of particular relevance for the on-site audit.
The lead auditor shall assess FRM.144-1 ISO 13485& MDR Surveillance/Recertification
Audit Information Form and UDFRM.121-1 MDR QMS Audit Program, UDFRM.107 MDR
Annual Technical Documentation Examination Plan and UDFRM.178 MDR Technical
Documentation and Site Sampling Plan and where applicable consider the advice of the
product reviewer(s) in order to define the audit scope of the surveillance.
From the UDFRM.121-1 MDR QMS Audit Program, the lead auditor can see the feedback
of the lead auditor(s) of the last assessment(s). Any article, in which a non-conformity is
detected in the last audit, shall be included in the scope of the surveillance audit. Similiarly,
any article, which is suggested to be assessed in the next audit by the Lead Auditor of the last
assessment, shall also be included in the scope of the surveillance audit. Moreover, by taking
into account the advice of the product reviewer(s) based on relevant technical
documentation and in order to determine whether the manufacturer meets the
requirements referred to in the relevant conformity assessment Annex, the lead auditor shall
review and plan the audit of the manufacturer's processes and subsystems, in particular for:
— design and development,
— production and process controls,
— product documentation,
— purchasing controls including verification of purchased devices,
— corrective and preventive actions, including for post-market surveillance, and
— PMCF,
and s/he shall review and audit requirements and provisions adopted by the manufacturer,
including those in relation to fulfilling the general safety and performance requirements set
out in Annex I.
In the sope of the surveillance audit, UDEM Adriatic d.o.o., where necessary, carries out or
asks for tests in order to check that the quality management system is working properly.
During the on-site audits, the audit team can accompany the manufacturer during any
UDEM Adriatic d.o.o
UDPD.04/ 06-03.06.2020/04.01.2018/Page:27/49
quality control testing and take a copy of the test report and sign it to prove this
accompaniment. The audit team adds the copy of the test report as an attachment to the
audit report.
In the case of Class III devices, the audit team conducts a test of the approved parts and/or
materials that are essential for the integrity of the device, including, where appropriate, a
check that the quantities of produced or purchased parts and/or materials correspond to the
quantities of finished devices.
UDFRM.22.02 CE Marking Site Audit Plan to the planning responsibleat least three days

After the audit, the lead auditor has to fill the relevant parts of FRM.121-1 MDR-QMS Audit
Programme Form in order to give feed back to the auditors, which will be assigned for the
next audits.
At the Medical Device Regulation audits, if the same minor non-conformity detected in two
consecutive years, the non-conformity become a major non-conformity and the observations
occur in two consecutive year, then they will become a minor non-conformity. That decision
is taken by the lead auditor in respect of the maturity of the system and developing aspects
of the client.
In Surveillance Audits; time required for the notification of objective evidence of the
implementation of the activities to our organization is 3 months at most after the audit. The
UDEM Adriatic d.o.o. audit team reviews corrective actions from the customer and gives
feedback to the customer organization about evaluation. If the objective evidence of
corrective actions from the client are found to be insufficient by the audit team, the
organization is notified in writing and additional work is requested. This period may not
exceed 6 months in any way. If the manufacturer is not able to close the major non-
conformities within 6 months, the certificate is suspended. If the decision of the follow up
audit is taken within the scope of the surveillance audit; a follow-up audit is planned if CPA’s
UDEM Adriatic d.o.o
UDPD.04/ 06-03.06.2020/04.01.2018/Page:28/49
from the manufacturer are found to be sufficient and effective by the lead auditor. The
follow-up audit should be planned within 3 months from the last day of the audit. In the
event that the follow-up decision is written on the basis of major non-compliance with the
safety of the product, the lead auditor informs the Project Leader, then s/he informs the
manufacturer of his recommendation for stopping manufacturing by means of the
UDFRM.33-1 MDR QMS Audit Report or UDFRM.33 MDR Certification Audit Report.
If non-conformities are not resolved or new non-conformities are detected in the follow-up
audit, the customer's certificate is suspended. The suspension period is maximum 6 months
after the certificate is suspended. If activities are not effective within the given period, the
certificate is withdrawn.
If the Lead Auditor can verify that the CPAs have been sufficiently and effectively
implemented based on objective evidence, s/he makes recommendations regarding the
continuation of certification in the audit report and finalizes and submits the audit file to the
Planning Responsible.
Maintenance of certification is possible through completion of major nonconformities.

Surveillance audit file should be reviewed by the Certification Committee with MFRM.12-1
MDR Committee Decison Report as in the first certification process and the decision of
maintanence of the certification shall be taken by the certification committee.
In case of a suspicious situation in the scope of the audit (use of different raw materials than
the declared one, product safety tests deemed not effective, inadequacy of the qualification
of the personnel performing the entrance quality, in-process control or final control tests
deemed inadequacy, fluctuating devices, equipment, machinery, noticing that IQ, OQ and/or
PQs are used without being done, validation of sterilization method change in validation,
supplier change, external process addition/removal status etc.) audit team can take samples
from site or market and send to test. Sampling considerations are carried out according to
the UDTLM.39 MDR Sampling Instruction.
If follow-up audit is required for two years and if it is originating from different materials, it
can be decided that the period of surveillance audits will be reduced from 1 year to 6 months
by a committee decision, or auditing can be arranged to the company.
10.1 Plan Surveillance Audits of Manufacturers with Vigilance Background
Once UDEM ADRIATIC D.O.O. receives information about the vigilance cases of the customer
organization from the manufacturer or the competent authorities or market surveillance
reports, which shall be provided according to Article 92 of MDR and/or according to Article
100 of MDR from EUDAMED,
it will decide which of the following options to apply:
UDEM Adriatic d.o.o

UDPD.04/ 06-03.06.2020/04.01.2018/Page:29/49
- not to take action on the basis that the vigilance case is clearly not related to the
certification granted,
- observe the manufacturer's and competent authority's activities and the results of the
manufacturer's investigation so as to determine whether the certification granted is at
risk or whether adequate corrective action has been taken,
- perform extraordinary surveillance measures, such as document reviews, short-notice
or unannounced audits and product testing, where it is likely that the certification
granted is at risk,
- increase the frequency of surveillance audits,
- review specific products or processes on the occasion of the next audit of the
manufacturer,
Review of vigilance information is conducted according to UDPD.12 MDR- Vigilance

Procedure.
10.2 Surveillance audits on temporary extraordinary situations
UDEM Adriatic d.o.o. shall conduct on-site surveillance audits at least once in 12 months. If
UDEM Adriatic d.o.o. cannot conduct the surveillance audit in this time period by any reason,
then the certificate shall be suspended until the audit has been carried out by UDEM Adriatic
d.o.o. However, in cases of epidemics, travel disabilities and similar extraordinary situations,
the on-site surveillance audits may be realized by remote audits or alternative methods
within this 12-month period according to the principles set out in UDPD.22 Extraordinary
Events Procedure.
11. RECERTIFICATION:
According to the Clause 9 of UDFRM.07 Medical Device Product Certification contract the
manufacturer shall submit an application to UDEM Adriatic d.o.o. at the latest 6 months prior
to the end of the validity of its certificate with the Application Form. UDEM Adriatic d.o.o
prepares a new offer for the re-certification and a new contract shall be signed mutually.
Moreover,
Planning responsible reviews UDEM Adriatic d.o.o’s certified client’s files every month and
determines clients, whose certification validity is approaching to the end.
S/he gets into contact with the client by sending the manufacturer FRM.144-1 ISO 13485&
MDR Surveillance/Recertification Audit Information Form FRM.81 Medical Devices
Certification Application Form if the manufacturer has an EU QMS Certificate or EU quality
Assurance Certificate and FRM.81 Medical Devices Certification Application Form and
UDFRM.216 EU Technical Documentation Assessment Recertification form, if the
manufacturer has EU Technical Documentation Assessment Certificate at the latest 6 months
prior the validity date of the certificate. UDEM Adriatic d.o.o. is conducted the pre-
application review to prepare an offer for the client. The application review and signing of
a new contract is conduct as the initial certification. However, the application review for the
EU Technical Documentation Assessment Certificate is conducted according to the section
11.1 of this procedure.
UDEM Adriatic d.o.o

UDPD.04/ 06-03.06.2020/04.01.2018/Page:30/49
The assessments are planned, implemented and completed as the initial certification
process, but the preliminary assessment of QMS and Technical Documentation is not
required.
The scope of the on-site audits and the procedure for reviewing the technical documentation
on representative basis is explained in the section 11.2 of this procedure for EU QMS
Certificate and EU Quality Assurance Certificate.
11.1 Recertification for EU Technical Documentation Assessment Certificates

The manufacturer, who has been granted with EU Technical Documentation Assessment
Certificate, shall submit FRM.81 Medical Devices Certification Application Form and
UDFRM. 216 EU Technical Documentation Assessment Recertification form.
With the UDFRM. 216 EU Technical Documentation Assessment Recertification form,

the manufacturer submits a summary of changes and scientific findings for the device to
UDEM Adriatic d.o.o, including;
(a)all changes to the originally approved device, including changes not yet notified,
(b)experience gained from post-market surveillance,
(c)experience from risk management,
(d)experience from updating the proof of compliance with the general safety and
performance requirements set out in Annex I,
(e)experience from reviews of the clinical evaluation, including the results of any clinical
investigations and PMCF,
(f)changes to the requirements, to components of the device or to the scientific or regulatory
environment,
(g)changes to applied or new harmonised standards, CS or equivalent documents, and
(h)changes in medical, scientific and technical knowledge, such as: — new treatments, —
changes in test methods,
— new scientific findings on materials and components, including findings on their
biocompatibility,
— experience from studies on comparable devices,
— data from registers and registries,
— experience from clinical investigations with comparable devices.
The manufacturer may use UDFRM. 216 EU Technical Documentation Assessment

Recertification form or may attach this summary of changes and scientific findings report
in the form.
This form is reviewed firstly in the application review stage by the project leader, internal
clinician and the product reviewer(s), who have the necessary MDR code(s) and is
nominated by the project leader. As a result of this evaluation, UDEM Adriatic d.o.o. may
refuse the application by the decision of the certification committee. The refusal of the
application shall be notified according to NOTIFICATION Procedure.
During the technical documentation assessment and the clinical evaluation assessment
UDEM Adriatic d.o.o reviews this summary report and clinical data from post-market
UDEM Adriatic d.o.o

UDPD.04/ 06-03.06.2020/04.01.2018/Page:31/49
surveillance and PMCF activities undertaken since the previous certification or re-
certification, including appropriate updates to manufacturers' clinical evaluation reports.
11.2 Recertification for EU QMS Certificate and EU Quality Assurance Certificate
UDEM Adriatic d.o.o audits the quality management system to determine whether it meets
the requirements of MDR. Where the manufacturer uses a harmonized standard or CS
related to a quality management system, UDEM Adriatic d.o.o assesses the conformity with
those standards or CS. UDEM Adriatic d.o.o assumes that a quality management system
which satisfies the relevant harmonized standards or CS conforms to the requirements
covered by those standards or CS, unless it duly substantiate not doing so.
In case of Class IIa and Class IIb devices (not implantable and sutures, staples, dental fillings,
dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors), the
project leader shall draw up a new sampling plan (FRM.178 MDR Technical
Documentation and Site sampling plan) with the re-certification by considering the
previous sampling plans according to UDTLM.50 INSTRUCTION FOR THE ASSESSMENT
OF TECHNICAL DOCUMENTATION. If there is any other device, which technical
documentation is not assessed during the certification period, then prioritization shall be
given to the assessment of these technical documentations. Moreover, if any information
according to article 92 and article 100 of MDR is transmitted to UDEM Adriatic d.o.o. during
the certification period, then the Project leader shall consider this information and prioritise
these devices, if any, in the sampling plan. S/he shall follow thre principles specified in
UDTLM.50 INSTRUCTION FOR THE ASSESSMENT OF TECHNICAL DOCUMENTATION.
Project leader shall assign site auditor(s) for the re-certification assessment according to the
principles set out in section 6.4 of this procedure by taking in account that a lead auditor
shall neither lead nor attend audits for more than three consecutive years in respect of the
same manufacturer.
The QMS documentation and FRM.144-1 ISO 13485& MDR Surveillance/Recertification

Audit Information Form and the previous UDFRM.121-1 MDR QMS Audit Program, and
UDFRM.178 MDR Technical Documentation and Site Sampling Plan, the last audit
reports are sent by the planning Responsible to the lead auditor via e-mail or via UDEM
Adriatic Software and if not feasible, a copy of it via shipping.
If the assessment of the technical documentation is accompanied with the re-certification

on-site QMS audit, then as explained in section 6.6 of this procedure; the UDEM ADRIATIC
D.O.O. can conduct the technical documentation assessment in the office or on the
manufacturer site dependent on the following conditions. If the technical documentation is
assessed on-site, then this assessment is accompanied with the QMS audit.
UDEM Adriatic d.o.o

UDPD.04/ 06-03.06.2020/04.01.2018/Page:32/49
If the QMS on site re-certification audit is conducted by auditors, who have the necessary
MDT codes but do not have the MDR/MDS codes; then the whole technical documentation
review shall be conducted in the office. In this case, the technical documentation review has
to be conducted prior to QMS re-certification audit, so that product reviewer(s) could give
their advice to the on-site audit team leader on aspects of the manufacturer’s design or
The lead auditor shall assess FRM.144-1 ISO 13485& MDR Surveillance/Recertification
Audit Information Form and previous UDFRM.121-1 MDR QMS Audit Program,
UDFRM.107 MDR Annual Technical Documentation Examination Plan and UDFRM.178
MDR Technical Documentation and Site Sampling Plan and where applicable consider
the advice of the product reviewer(s) in order to define the audit scope of the re-
certification.
From previous the UDFRM.121-1 MDR QMS Audit Program, the lead auditor can see the
feedback of the lead auditor(s) of the last assessment(s), including surveillance audits,
unannounced audit(s) and all audits carried out at subcontractors and suppliers. Any article,
in which a non-conformity is detected in the last audit or any weak points in the
manufacturer/subcontractor/supplier’s QMS, which are detected in the last audits shall be
included in the scope of the re-certification audit. Similiarly, any article, which is suggested
to be assessed in the next audit by the Lead Auditor of the last assessment, shall also be
included in the scope of the re-certification audit. Moreover, by taking into account the
advice of the product reviewer(s) based on relevant technical documentation and in order to
determine whether the manufacturer meets the requirements referred to in the relevant
conformity assessment Annex, the lead auditor shall review and plan the audit of the
manufacturer's processes and subsystems, in particular for:
— corrective and preventive actions, including for post-market surveillance, and vigilance
system of the manufacturer
— PMCF and risk management,
and s/he shall review audit requirements and provisions adopted by the manufacturer,
out in Annex I.
11.3 Decision on Recertification
UDEM Adriatic d.o.o

UDPD.04/ 06-03.06.2020/04.01.2018/Page:33/49
The decision on recertification is conducted according to the article 8. DECISION OF

CERTIFICATION of this procedure.
The new certificate is issued with the report prepared after the audit and product
recertification decision is made by the Certification Committee following the Review process.
The new certificate is issued following the recertification decision made by the Certification
Committee. First certificate’s date of issue is also specified in the new certificate. Validity
period of this new certificate can not exceed 5 years from the day the recertification decision
is made.
If the reasessment assessments are not completed before the expiry date, or if it can not be
verified that the corrective action plan for any minor non-conformity and corrective actions
for any major nonconformity have been applied, then re-certification is not recommended
and the validity of the certification is not extended. The customer is informed and the results
are explained.
12. TERMINATION, SCOPE REDUCTION, SUSPENSION, REINSTATEMENT AND

WITHDRAWAL PROCESSES FOR THE CERTIFICATION
As a result of surveillance activities or when a nonconformity with the certification

conditions has been proved, UDEM ADRIATIC D.O.O. takes this situation into consideration
and in respect to this puts the relevant following activities into action;
12.1 Suspension
UDEM ADRIATIC D.O.O. suspends its clients’ certifications in the following situations:
1. If the client consistently and seriously fails at meeting the certification conditions for
certified products,
2. If the client does not allow that surveillance and recertification examinations are
conducted as often as required,
3. If the client voluntarily requests for temporary suspension.
4. If UDEM ADRIATIC D.O.O. finds a divergence between the sample taken from the devices
produced or from the market and the specifications laid down in the technical
documentation or the approved design, UDEM ADRIATIC D.O.O. will suspend the relevant
certificate or impose restrictions on it.
5. During surveillance audits, if there is a major non-conformity raised about product safety
that require follow-up audit, and there are threatening situations for the user's health
(sterilization process mistrust suspicious raw material use etc.), after the audit team reports
and submit related non-conformities within 7 days to the committee, it may decide the
suspension of related EU Certificate/s depending on the critic. (Critical condition:
threatening the health of the patient seeks decided to stop production of the product on the
grounds.)
6. If follow-up audit is required for the two consequtive years and if the cause of follow-up is
derived from the same items; related EU certificates can be suspended with the approval of
the committee. Unannounced audits can be carried out in case of suspension.
UDEM Adriatic d.o.o

UDPD.04/ 06-03.06.2020/04.01.2018/Page:34/49
UDEM ADRIATIC D.O.O. informs client about the committee decision for suspension. Status
of the client whose certification has been suspended is accessible through web site of UDEM
ADRIATIC D.O.O. Moreover, FRM.34.M Conditions of Suspension and Withdrawal
Process which defines client’s rights during suspension process is sent to the client.
During the suspension, client’s certificate is provisionally invalid. For this reason, the client
should avoid any activity that may advertise client certification in this period. In case the
certification is suspended or withdrawn the organization has to stop use of logos and
certificates. (See Logo and Certificate Usage Instructions).
Suspension period can not exceed 6 months. Suspension period is followed by UDEM
Adriatic software. The project leader may review the suspension period in the interface of
the client’s file. Moreover, UDEM Adriatic software send an automated E-mail to the project
leader prior 1 month of the end of the suspension period. Moreover, the planning
responsible Planing Responsible reviews UDEM ADRIATIC D.O.O. Client Portal every month
and determines the end of the suspension period of the client. S/he shall inform the project
leader of this client.
12.2 Reinstatement
In case the result of the follow-up audit carried out for corrective actions is positive, the
prepared audit report is presented to the Certification Committee by the MDTRR. Restoring
decision of the certificate shall be taken by certification committee. After the committee
decision EU certificate is reissued with a revison number.
12.3 Withdrawal
If it is realized that the client whose certification has been suspended and not completed the
nonconformities during the suspension period or does not fulfill any of the certification
requirements, certification will be withdrawn. Withdrawing the certification means the
cancellation of client’s certification by UDEM ADRIATIC D.O.O. and terminating of the
contract. UDEM ADRIATIC D.O.O. informs client about the committee decision for
withdrawn. Client whose certification has been withdrawn has to apply to our company
again if they would like to receive any service from us.
If client does not apply for the follow-up audit within 6 months after the client’s certificate
has been suspended, additional time may be given by the Certification Committee decision
or the certificate may be withdrawn.
Certification is withdrawn under conditions such as:
 Upon request of client,
 Bankruptcy of the client and terminating its operations under the scope of
certification,
 Change in the legal entity of the client,
 approval of the suspension requirements by the client,
 Client’s not eliminating the suspension reasons,
 Client’s not giving confirmation for the realization of follow-up audits at the end of
suspension period,
UDEM Adriatic d.o.o

UDPD.04/ 06-03.06.2020/04.01.2018/Page:35/49
 Not closing out the nonconformities raised during the follow-up audits which are
performed in order to eliminate the suspension status in foreseen time,
 Use of certificate by the client in fields of product or service which is different
from that declared in certificate scope in a deceptive and unfair way,
 Absence of client at the address of plant declared in certificate,
 Falsification of records over certificate,
 Disapproval of client for the surveillance audit date on time.
 If the multisite client fails to inform UDEM ADRIATIC D.O.O. about the closing of
any of its sites or branches, certification is withdrawn. Certification is cancelled entirely
if the central office or any of the sites fail to fulfill the requirements related with the
maintenance of certification.
 If UDEM ADRIATIC D.O.O. finds a divergence between the sample taken from the
devices produced or from the market and the specifications laid down in the technical
documentation or the approved design, UDEM ADRIATIC D.O.O. will withdraw the
relevant certificate or impose restrictions on it.
 In the first audit carried out for a company which has been suspended, the
withdrawal decision shall be taken in case of re-suspension reasons.
Client body has to implement the following liabilities if the certificate is withdrawn:
 Termination of the use of UDEM ADRIATIC D.O.O. certificate and logo,
 To discontinue all of the rights under the scope of certificate withdrawn,
 To pay for the certificate and audit fees for which have not been paid before.
Client body is supposed to remove UDEM ADRIATIC D.O.O. logo from each kind of
correspondence and introductory material within one month following the withdrawal of
certificate. Otherwise UDEM ADRIATIC D.O.O.;
 Informs the related accreditation body and other certification bodies,

 Declares that the client body uses the certificate illegally by violating the terms of
contract in various broadcasting firms,
 Takes legal actions for the removal of material and immaterial harms that will arise as
a result.
After the withdrawal of the certificate, the following actions will be taken in accordance with
the vigilance plan of the client.
Moreover, certificate is withdrawn and it is announced to the public opinion if the client
body does not ask for recertification, the production/service within the scope of certificate is
terminated or the company is closed.
In addition, clients whose certifications have been withdrawn have to stop all their activities
with respect to certification and advertising affairs. Otherwise UDEM ADRIATIC D.O.O. takes
legal actions. After exceeding this time limit, if the client wants to get certification service
again first certification process shall be initiated.
12.4. Scope Reduction
If client fails consistently and seriously at meeting certification requirements for a part of the
product certification scope, UDEM ADRIATIC D.O.O. narrows client’s product certification
scope in a way to exclude the part that does not meet the requirements. When Product
UDEM Adriatic d.o.o

UDPD.04/ 06-03.06.2020/04.01.2018/Page:36/49
Certification scope has been narrowed, the client should change all the advertising materials.
CE Marking should be removed from products left out of the scope. Certification scope may
be restricted on the request of the client. EU Declaration of Conformity and UDEM ADRIATIC
D.O.O. product certificate are demanded from the client whose certification scope has been
restricted. The new certificate is issued and then submitted. Need for scope narrowing may
come up during audits or when the client does not comply with the necessary conditions. In
general, audits are not conducted to narrow the scope. Status of the client with narrowed
scope shall be published on UDEM ADRIATIC D.O.O.’s website.
12. 5 Notification
All notifications regarding the status of certification is conducted ccording to UDPD.10.

Medical Device Notifications Procedure which contains notification via electronic system
according Article 57 of MDR. Status of the client whose certification has been suspended,
withdrawn or reduced is accessible through web site of UDEM ADRIATIC D.O.O.. Moreover,
FRM.34.M Conditions of Suspension and Withdrawal Process which defines client’s
rights during suspension and withdrawal process is sent to the client.
13. SPECIAL ON-SITE AUDITS:
13.1Unannounced Audit Process:

UDEM ADRIATIC D.O.O. conducts unannounced audits so that continuity of compliance with
legal requirements is verified.
UDEM Adriatic d.o.o. performs randomly at least one every five years unannounced audits
on the site of the manufacturer and, where appropriate, of the manufacturer’s suppliers
and/or subcontractors, which may be combined with the periodic surveillance assessment
described in detail in the section 10 of this procedure or be performed in addition to the
surveillance assessment.
The acceptance of the unannounced audits of the manufacturer and where appropriate the
subcontractors and suppliers of the manufacturer is ensured with the certification contract.
Moreover, the manufacturer shall send UDEM Adriatic d.o.o. an invitation letter without a
date after she has been granted with a certificate, where the visa is necessary for UDEM
Adriatic d.o.o.’s personnel.
The frequency of the unannounced audits is dependant on the risk class of the device. For
Class III devices, unannounced audits are conducted at least once every three years, for Class
II-b and devices with the novelty of the technology other than Class III devices at least once
every four years and in all other cases at least once every five years. If there is more than one
device in the scope of the certificate, then the frequency of the unannounced audit is
determined according to the riskiest device.
As a result of the information, which is transmitted to UDEM Adriatic d.o.o. from EUDAMED
according to Article 92 (vigilance) and Article 100 of MDR (market surveillance), the
UDEM Adriatic d.o.o

UDPD.04/ 06-03.06.2020/04.01.2018/Page:37/49
frequency of the unannounced audit is increased according to the principles set out in
UDPD.12 MDR- Vigilance Procedure.
Timing of unannounced audits shall be planned unpredictably and when the production is
active. The critical components and materials, which preferably produced and used recently
from the ongoing production, shall be verified to meet the conformance of the requirements
specified in QMS documentation together with the traceability records.
After each certification decision, the project leader, who is appointed for the particular
project, shall review the assessment reports and especially UDFRM.121-1 MDR QMS Audit
Program to determine the unannounced audit date for each manufacturer. S/he shall record
this date to UDFRM.123 MDR Unannounced Audit Plan.
UDFRM.121-1 MDR QMS Audit Program includes the information necessary for the
planning of the unannounced audit. For example: information regarding to the shifts of the
production and seasonal stopping of the production; the information regarding to the
supplier and/or subcontractor’s assessment. Therefore, by reviewing this form, the project
leader can determine a date as month/year and ensure an accurate prediction for the
production to be active at the unannounced audit date.
UDFRM.123 MDR Unannounced Audit Plan shall be reviewed and verified after each
surveillance audit by the Project Leader in order to verify the planned unannounced audit.
The project leader shall review the section of UDFRM.121-1 MDR QMS Audit Program
related to the last surveillance assessment. Any amendment shall be recorded in the
related section of UDFRM.123 MDR Unannounced Audit Plan.
The planned date of the unannounced audit may be updated by the project leader according
to the result of the evaluation of the information, which is transmitted to UDEM Adriatic
d.o.o. from EUDAMED according to Article 92 (vigilance) and Article 100 of MDR (market
surveillance).
Any amendment of the unannounced audit date shall be recorded in the related section of
UDFRM.123 MDR Unannounced Audit Plan. This from shall be kept in the client’s file.
The project leader shall review the client’s file every January of each year, and shall notify
the planning responsible for the unannounced audits. The assignment of the auditors for an
announced audit is made by the project leader with the same method of the surveillance
audits.
These audits are carried out at least one day and at least with two site auditors, at least one
of them has the necessary MDT code(s) for the medical device technology.
The Planning Responsible arranges accommodation, transportation etc. for the audit team.
requirements, which will be reviewed during the unannouced audit.
UDEM Adriatic d.o.o

UDPD.04/ 06-03.06.2020/04.01.2018/Page:38/49
The lead auditor shall not send the UDFRM.22.02 CE Marking Site Audit Plan to the
manufacturer.
During the unannounced audit QMS documentation of the manufacturer is reviewed with
using UDFRM.104 MDR Unannounced Audit Report according to UDPD.18 MDR Annex
IX Conformity Assessment Procedure or UDPD.19 MDR Annex XI PART A Conformity
Assessment Procedure depending on the type of the application.
The lead auditor shall review and plan the audit of the manufacturer's processes and
subsystems, in particular for:
— PMCF,
During the unannounced audits, at least 2 critical processes (for exp: sterilization, packaging,
input control, design control etc.), product safety and non-conformities of the producer shall
be taken into consideration and examined in detail.
Within the context of this unannounced on-site audits, the site auditors may test sample of
the devices produced or an adequate sample from the manufacturing process to verify that
the manufactured device is in conformity with the technical documentation, with the
exception of Class III implantable custom-made devices, which is defined in UDTLM.39
Sampling Instruction. The audit team may accompany the manufacturer during any quality
control testing and take a copy of the test report and sign it to prove this accompaniment.
The audit team shall request from the the Project leader, to buy a sample from the market.
Tests, which shall be recorded in UDFRM.104 MDR Unannounced Audit Report, are
carried out to verify that the manufactured device is in conformity with the technical
documentation.
The audit team determines which tests shall be done on the sample according to the
following principles. They shall consider the result and findings of the audit. If they have
realized any risk in a manufacturing process, then they shall request the test related with
this particular manufacturing process. For example, if they find that a manufacturer’s
procedure for a process validation of an injection molding process requires annual review of
the process and the annual review was not performed, however there were no changes or
process deviations noted. In that case, there is a risk that the device may not meet the
performance requirements in the harmonized standard. In this case, they shall request a test
for the conformance of the harmonized standard. Similarly, if they find in the unannounced
site audit that the number of the personnel who works in the clean room was increased
because the production capacity of the manufacturer was increased. In that case, they shall
consider the risk of increasing the bioburden on the product, and they shall request the
sterility test. The requested tests shall be related to the safety and performance of the device
which may include biocompatibility test, electrical safety tests, biomechanical tests etc.
UDEM Adriatic d.o.o

UDPD.04/ 06-03.06.2020/04.01.2018/Page:39/49
The project leader shall send the sample to one of the subcontracted laboratories, who has
the capability to conduct the requested test(s).
The non-conformities are reported and assessed in accordance with the principles set out in
Section 10 of this procedure. The following documents are used during the on-site
unannounced audits:
DOCUMENTS
MFRM.06-1 Auditor Declaration
MFRM.27 CE Marking Audit Meeting Minutes
UDFRM.22-02.CE Field Audit Plan
UDFRM.104 MDR Unannounced Audit Report
UDFRM.121-1 MDR QMS Audit Program
UDFRM.123 MDR Unannounced Audit Plan.
MFRM.164 MDR Observation and Non-conformity Form
UDFRM.157 Medical Device Additional Sampling Report
13.2 Short-Term On-site audits

Furthermore, UDEM Adriatic d.o.o. conducts short-term audits in order to investigate
complaints,and to follow suspended clients and as the result of the evaluation of the
information supplied according to Article 92 of MDR and/or according to Article 100 of
MDR. These audits are planned in a short time, announced to clients and their approval is
obtained. However, owing to this short time ultimate attention is required while assigning
the audit team, because this time may be extended if the client objects. The client has
accepted to cover expenses required for special audits by signing Certification Contract form
at the beginning of certification process.
Short-term audit process comprises the stages from planning of the audit to writing the
audit report and decision on certification. The audit Report, which is used in the surveillance
on-site audits, shall be filled in and submitted to Product Certification Committee.
Short notice audit process includes the stages from audit planning to certification decision
after the audit report is written. UDFRM.33 MDR Certification Audit Report or
UDFRM.33-1 MDR QMS Audit Report can be used according to type of reason for short
notice audit.
The audit scope is limited to the complaints or the information supplied according to Article
92 of MDR and/or according to Article 100 of MDR.
14. TRANSFER AUDITS

14.1 Application Review
UDEM ADRIATIC D.O.O.’s Project Leader conducts the application review with the
UDFRM.160 MDR Voluntary NB Transfer Review Form.
When necessary, UDEM ADRIATIC D.O.O. communicates with the former notified body and
UDEM Adriatic d.o.o

UDPD.04/ 06-03.06.2020/04.01.2018/Page:40/49
provides the following information:

1. The documentation of the client (documentation of previous assessments, the
objective evidence of completion of the nonconformities etc.) and the technical
information
2. Information that the client has not concluded an agreement for the continuation of
the certification with outgoing NB and cancellation of the contract,
3. Mutual agreement on when the cancelation of the certificate by outgoing NB ensured
and when the new NB will issue the certificate.
4. the last serial number or lot number for which the outgoing notified body is
responsible.
5. Validity date of current certificate and certificate number
14.2 Agreement Requirements

UDFRM.159 MDR Voluntary Transfer Agreement which is signed between customer and
UDEM ADRIATIC D.O.O. contains the certification cycle determined by former NB.
This agreement shall be signed between manufacturer, outgoing NB and UDEM ADRIATIC
D.O.O. UDFRM.159 MDR Voluntary Transfer Agreement contains the following
information;
(a) the date on which the certificates issued by the outgoing notified body become invalid;
(b) the date until which the identification number of the outgoing notified body may be
indicated in the information supplied by the manufacturer, including any promotional
material;
(c) the transfer of documents, including confidentiality aspects and property rights;
(d) the date after which the conformity assessment tasks of the outgoing notified body is
assigned to the incoming notified body;
(e) the last serial number or lot number for which the outgoing notified body is responsible.
The outgoing notified body shall withdraw the certificates it has issued for the device
concerned on the date on which they become invalid, which is ensured by the UDFRM.159
MDR Voluntary Transfer Agreement.
14.3 Voluntary change of notified body

14.3.1. Transfer audits for EU QMS Certificate and EU Quality Assurance Certificate
For quality management system certificates (EU QMS Certificate and EU Quality Assurance
Certificate), UDEM Adriatic d.o.o. needs to perform appropriate on-site audit(s) and
assessments to ensure that the manufacturer in question applies the approved QMS and the
post-market surveillance plan prior to the issue of any certificate. In respect to the
assessment of technical documentations on a sampling basis, UDEM Adriatic d.o.o. shall
review the previous assessment results together with a sample of a technical documentation
and draw up or amend a sampling plan.
In case of Class IIa and Class IIb devices (not implantable and sutures, staples, dental fillings,
dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors), the
UDEM Adriatic d.o.o

UDPD.04/ 06-03.06.2020/04.01.2018/Page:41/49
project leader shall draw up a sampling plan (FRM.178 MDR Technical Documentation
and Site sampling plan) with the voluntary change of NB by considering where available
the previous sampling plan of the former NB according to UDTLM.50 INSTRUCTION FOR
THE ASSESSMENT OF TECHNICAL DOCUMENTATION. If there is any other device, which
technical documentation is not assessed during the certification period by the former NB,
then prioritization shall be given to the assessment of these technical documentations. S/he
shall follow thre principles specified in UDTLM.50 INSTRUCTION FOR THE ASSESSMENT
OF TECHNICAL DOCUMENTATION.
The assessments are planned, implemented and completed as the initial certification
process, but the preliminary assessment of QMS is not required.
Project leader shall assign site auditor(s) for the transfer assessment according to the
principles set out in section 6.4 of this procedure.
The QMS documentation and if available the previous assessment reports and the audit
program of the former NB, and UDFRM.178 MDR Technical Documentation and Site
Sampling Plan are sent by the planning Responsible to the lead auditor via e-mail or via
UDEM Adriatic Software and if not feasible, a copy of it via shipping.
If the assessment of the technical documentation is accompanied with the transfer on-site
QMS audit, then as explained in section 6.6 of this procedure; the UDEM ADRIATIC D.O.O. can
conduct the technical documentation assessment in the office or on the manufacturer site
dependent on the following conditions. If the technical documentation is assessed on-site,
then this assessment is accompanied with the QMS audit.
If the QMS on site transfer audit is conducted by auditors, who have the necessary MDT
codes but do not have the MDR/MDS codes; then the whole technical documentation review
shall be conducted in the office. In this case, the technical documentation review has to be
conducted prior to QMS re-certification audit, so that product reviewer(s) could give their
advice to the on-site audit team leader on aspects of the manufacturer’s design or
The lead auditor shall assess if available the previous assessment reports and the audit
program of the former NB and UDFRM.178 MDR Technical Documentation and Site
Sampling Plan and where applicable consider the advice of the product reviewer(s) in order
UDEM Adriatic d.o.o

UDPD.04/ 06-03.06.2020/04.01.2018/Page:42/49
to define the audit scope of the transfer audit.
From previous the Audit Program of the former NB, the lead auditor can see the feedback of
the lead auditor(s) of the last assessment(s). Any article, in which a non-conformity is
detected in the last audit, shall be included in the scope of the transfer audit. Similiarly, any
article, which is suggested to be assessed in the next audit by the Lead Auditor of the last
assessment, shall also be included in the scope of the transfer audit. Moreover, by taking into
account the advice of the product reviewer(s) based on relevant technical documentation
and in order to determine whether the manufacturer meets the requirements referred to in
the relevant conformity assessment Annex, the lead auditor shall review and plan the audit
of the manufacturer's processes and subsystems, in particular for:
— PMCF,
and s/he shall review, and audit requirements and provisions adopted by the manufacturer,
out in Annex I.
The decision on transfer audit is conducted according to the article 8. DECISION OF
14.3.2. Transfer assessments for EU Technical Documentation Assessment Certificate

For EU Technical Documentation Assessment Certificate, new certificates without a
comprehensive (initial) review may be issued as long as the documentation received does
not identify ongoing existing or other concerns.
If any of the assessment reports of the former NB is not available or the conclusions of the
former NB are not clear, then the same procedure of the initial certication shall be applied.
The project leader nominates product reviewers, who have the necessary MDR/MDS codes
for the device, shall review the technical documentation and the assessment reports of the
former NB and where available the scientific opinion of the medicinal products consulted by
using UDFRM.33 MDR Certification Audit Report. If they detect any non-conformity, then
the manufacturer is notified to implement CAPA with UDFRM.164 MDR OBSERVATION
AND NON-CONFORMITY REPORT.
The project leader nominates a Clinical Expert, who has the relevant MDR code, in
UDEM Adriatic d.o.o

UDPD.04/ 06-03.06.2020/04.01.2018/Page:43/49
coordination with the internal clinician. Clinical experts assesses the clinical documentation
of the manufacturer and the assessment report of the former NB, including CEAR and the
assessment reports of PSUR and the PMCF evaluation report. If they detect any non-
conformity, then the manufacturer is notified to implement CAPA with UDFRM.164 MDR
OBSERVATION AND NON-CONFORMITY REPORT.
The decision on transfer audit is conducted according to the article 8. DECISION OF

14.3.3 For voluntary change process should be provided the following:
1. The manufacturers shall inform UDEM ADRIATIC D.O.O. about the date of completion
of the relevant products and their release to the market,
2. The manufacturer shall notify the outgoing NB of the certificate issued by the UDEM
ADRIATIC D.O.O.
3. Manufacturer can use the NB number of the outgoing NB in labeling up to 6 months
for the products on the market. (The outgoing NB may extend this period when the
manufacturer provides its reasons.)
4. UDEM ADRIATIC D.O.O. will take over all Conformity Assessment tasks /
responsibilities,
5. UDEM ADRIATIC D.O.O. is responsible for carrying out the Quality System and
Surveillance Audits.
6. Ownership of certificates provided by the outgoing NB belongs to the outgoing NB.
7. The remuneration information or debts belonging to the outgoing NB are the
responsibility of the manufacturer.
8. Changes to the CE marking and lot numbers on the product shall be documented by
the manufacturer.
9. If the outgoing NB is not in communication with UDEM ADRIATIC D.O.O., UDEM
ADRIATIC D.O.O. notifies the competent authority. UDEM ADRIATIC D.O.O. reviews all
documantation according to the initial certification process.
15. CONFORMITY ASSESSMENT ACTIVITIES
15.1 Classification: Devices are divided into Classes I, IIa, IIb and III according to the risk in
terms of the potential risks arising from the design and manufacture and human health.
Evaluation and verification of the classification is carried out according to UDTLM.19
Medical Device Classification Instruction.
15.2 Clinical and technical documentation of the medical devices: Clinical and technical
documentation of medical devices is carried out according to UDPD.16 MDR-Pre-Clinical
Evaluation Procedure, UDPD.17 MDR- Clinical Evaluation Procedure, UDPD.14 MDR-
UDEM Adriatic d.o.o

UDPD.04/ 06-03.06.2020/04.01.2018/Page:44/49
Risk Management Procedure, UDPD.15 MDR- Post Market Surveillance Procedure,

UDTLM.50 MDR-Technical Documentation Assessment Instruction
15.3 QMS and Technical Documentation Review of medical devices: If the customer
request is a conformity assessment according to MDR 2017/745/EU ANNEX IX Chapter I or
Chapter II, UDPD.18 MDR Annex IX Conformity Assessment Procedure is conducted, if
the customer request is a conformity assessment according to MDR 2017/745/EU ANNEX XI
PART A, UDPD.19 MDR Annex XI PART A Conformity Assessment Procedure is
conducted.
15.4 If the medical devices incorporates medicinal substance or substances

absorbed by human body, UDPD.20 MDR-Procedure for Examination of Medical
Devices Incorporating Medicinal Substance or Substances Absorbed by Human Body is
conducted.
15.6 Review of vigilance information: Vigilance process is conducted according to

UDPD.12 MDR- Vigilance Procedure.
15.7 If the result of Technical Documentation Examination Report and Audit Report is
negative, UDEM ADRIATIC D.O.O. indicates the reasons clearly and refuses to give certificate.
UDEM ADRIATIC D.O.O. publishs in web site the name of these companies. UDEM ADRIATIC
D.O.O. makes all notifications according to UDPD.10. Medical Device Notifications
Procedure.
15.8 UDEM ADRIATIC D.O.O. accepts all documents and certificates of custumers prepared
in Croatian and English.
15.9 Technical Documentation of companies are examined by UDEM ADRIATIC D.O.O.
periodically. If there is no change in the Certification cycle in all technical documentation,
should be reviewed at least once. Technical Documentation Evaluation Systematic has been
defined in UDTLM.50 Technical Documentation Assessment Instruction.
15.10 Conformity Assessment Notifications: Conformity Assessment Notifications are

conducted according to UDPD.10. Medical Device Notifications Procedure, UDPD.10
Annex 1 Notifications Table.
16. ADVERTISEMENT OF CONFORMITY ASSESSMENTACTIVITIES of UDEM ADRIATIC

D.O.O.
UDEM ADRIATIC D.O.O., advertises the conformity assessment activities via the information
presented in the www.udemadriatic.com and by attending the fairs related with the medical
device industry and preparing promotional materials, which are prepared to give
information to the potential clients about the conformity assessment activities given by
UDEM ADRIATIC D.O.O. The promotional material and advertising activities are approved by
the General Manager according to the principles set out in this section.
16.1. Checking and Approval of the Web Site

UDEM Adriatic d.o.o
UDPD.04/ 06-03.06.2020/04.01.2018/Page:45/49
The content of the web site related to the MDR conformity assessment activities, as well as,
other sections of the website shall be checked by MDTRR, Management Representative and
General Manager. The aim of this control is to check any information in the web site of UDEM
ADRIATIC D.O.O. in no way implies or is capable of leading to an inference that UDEM
ADRIATIC D.O.O.’s conformity assessment will offer manufacturers earlier market access or
be quicker, easier or less stringent than that of other notified bodies.
Anyone, who plans to publish something in the website, shall send the content to the
Management Representative (MR). MR shall arrange a meeting with MDTRR and General
Manager. They check the proposed content of the website. If any information in that section
does not conform to the abovementioned requirement, then they ask to change this
information and a training is given to the person who prepares the content by the MDTRR.
The content of the training is “Annex VII of MDR”. The records are taken by the MR in
FRM.37 MRM Minutes Form. If the proposed section conforms to the abovementioned
requirement, then this section will be printed out and signed by the General Manager. After
the approval of the General Manager, the proposed content will be published in the web site.
(www.udemadriatic.com)
Moreover, the content of the website is checked annually to ensure the content of the web
site of UDEM ADRIATIC D.O.O. in no way implies or is capable of leading to an inference that
UDEM ADRIATIC D.O.O.’s conformity assessment will offer manufacturers earlier market
access or be quicker, easier or less stringent than that of other notified bodies.
MR shall arrange a meeting in February of each year to check the content of the website. MR,
MDTRR and General Manager shall attent to this meeting. During this meeting, they shall
check the UDEM ADRIATIC D.O.O. web site whether there is any information or not about the
abovementioned condition. They shall also check the websites of any other party such as
web sites of the subcontractors, make a search in a search engine about UDEM ADRIATIC
D.O.O. If they find any information which does not conform the abovementioned condition,
then a CAPA shall be initiated by MR according to PD.05 PROCEDURE FOR THE
ASSESSMENT OF NONCONFORMITIES AND CPA. All records of this meeting are taken by MR
in FRM.37 MRM Minutes Form.
16.2. Checking and Approval of the Promotional Materials
The content of any promotional material related to the MDR conformity assessment
activities, as well as, other services which are presented by UDEM ADRIATIC D.O.O., shall be
checked by MDTRR, Management Representative and General Manager. The aim of this
control is to check any information in the promotional materials of UDEM ADRIATIC D.O.O.
in no way imply or are capable of leading to an inference that UDEM ADRIATIC D.O.O.’s
conformity assessment will offer manufacturers earlier market access or be quicker, easier
or less stringent than that of other notified bodies.
Anyone, who prepares a draft promotional material, shall send the content to the
Management Representative (MR). MR shall arrange a meeting with MDTRR and General
UDEM Adriatic d.o.o
UDPD.04/ 06-03.06.2020/04.01.2018/Page:46/49
Manager. They check the content of the proposed promotional material. If any information in
that material does not conform to the abovementioned requirement, then they ask to change
this information and a training is given to the person who prepares the content by the
MDTRR. The content of the training is “Annex VII of MDR”. The records are taken by the MR
in FRM.37 MRM Minutes Form. If the proposed promotional material conforms to the
abovementioned requirement, then the first copy of this promotional material will be
printed out and signed by the General Manager. After the approval of the General Manager,
this promotional material will be used in the advertising activities of UDEM ADRIATIC D.O.O.
The abovementioned process shall also be implemented to any material which are presented
by UDEM ADRIATIC D.O.O. in a trade fair.
16.3. Training of the Personnel
Any person, who has a contact with the client in the behalf of UDEM ADRIATIC D.O.O., such
as Planning Responsible, or any person who attends to the fair, shall be trained by MDTRR
about the Annex VII of MDR. There shall be an exam after the training. The person shall have
at least 70 out of 100 to be succesfull. If the person fails the exam, then the training is
repeated.
Any person, who has not an abovementioned training, shall not communicate with the
clients or potential clients about the UDEM ADRIATIC D.O.O conformity assessment activities
in MDR.
17- COORDINATION OF UDEM ADRIATIC D.O.O. WITH OTHER NOTIFIED BODIES

UDEM ADRIATIC D.O.O. is in contact with other Notified Bodies through its memberships in
CIRCABC and NB-Net (Notified Bodies Network, NB-MED), and participates regularly in the
meetings of relevant associations and organizations. The Management Representative keeps
track of and ensure regular participation in semi-annual horizontal group meetings held
once every six months among Notified Bodies.
Medical Devices Technical Regulation Responsible attends the NB-MED meetings at least
once a year and submit the important and necessary information to the related personnel.
The Commission ensures that appropriate coordination and cooperation between bodies
notified under MDR are put in place and properly operated in the form of a Coordination
Group of Notified Bodies for Medical Devices. Member States ensures that the bodies notified
by them participate in the work of that Group, directly or by means of designated
representatives. UDEM ADRIATIC D.O.O. uses the resulting administrative decision and
documentation as a general guideline.
Description of Revision
Part No. Revision Date Rev. No.
All
25.02.2019 01 All document has been reviewed.
Document
UDEM Adriatic d.o.o

UDPD.04/ 06-03.06.2020/04.01.2018/Page:47/49
Article “17- COORDINATION OF UDEM ADRIATIC D.O.O. WITH

In 34.
16.04.2019 02 OTHER NOTIFIED BODIES” has been added.
Page
The inconsistence in the procedure has been eliminated.
“UDEM” has been changed as “UDEM Adriatic d.o.o”
The procedure has been divided into three sections (16.1, 16.2
and 16.3). Detailed information has been added about the
advertising activities of UDEM ADRIATIC D.O.O.)
The procedure has been revised, Application pre-review
process is introduced, and also application review is detailed
and a new pre-application review form (FRM82-2) is introduced
into the system).
The wrong job descriptions are deleted from the procedure and
corrected to eliminate the inconsistence.
Section 5.2.2.2 has been introduced in the procedure and
section 6.1 is detailed.
Section 6 of the procedure, new section 6.2 is introduced
Pre-application review and application review also in section
6.1 the hierarchical allocation of the codes has been determined.
Section 10 of and Section 13 of procedure have been revised in
order to define the scope and criteria for different audits
Section 7.5.3.1 has been introduced in the procedure to ensure
that the audit findings are appropriately and consistently
classified.
Section 10 has been revised to eliminate over-the-counter
situations and to ensure that surveillance assessment at least
once every 12 months)
Section 8.3 has been reviewed and revised in order to define
The documented estimate of planned changes and assessment of the
whole 26.08.2019 03 changes made, including measures to verify the significance of
document the change and the different decisions regarding to planned
changes.
Section 12.1 has been defined that “Suspension period is
followed by UDEM Adriatic software. The project leader may
review the suspension period in the interface of the client’s file.
Moreover, UDEM Adriatic software send an automated E-mail to
the project leader prior 1 month of the end of the suspension
period. Moreover, the planning responsible Planing Responsible
reviews UDEM ADRIATIC D.O.O. Client Portal every month and
determines the end of the suspension period of the client. S/he
shall inform the project leader of this client.”
Section 11 has been reviewed and clauses which defines a
deviation from the legal requirements are deleted
Section 11 has been reviewed and revised to define fully the re-
certification requirements and for the EU QMS certification, eg
the scope of the on-site audit is not specified or the procedure
for reviewing the technical documentation on a representative
basis and a new form EU technical documentation assessment
recertification form is introduced
Section 10 and Section 13 are revised in order to define the
scope and criteria for different audits
Section 7.5.3.1 is introduced in the procedure to ensure that the
audit findings are appropriately and consistently classified)
Section 10 is revised to eliminate over-the-counter situations
and to ensure that surveillance assessment at least once every
12 months.
UDEM Adriatic d.o.o

UDPD.04/ 06-03.06.2020/04.01.2018/Page:48/49
The section 14 has been reviewed and revised to implement

MDR requirements about the procedure for voluntary change of
NB.
All of the red parts have been added new. All the revisions have
been made regarding the NCRs detected during Ministry Health
and EU Commission Joint Assessment.
Section Header of Section 14.3.3 was written as 14.3.1 by mistake. It
01.11.2019 04
14.3.3 was corrected as 14.3.3.
In the Section 11.2 paragraph 9, the “last assessments” are
defined more clearly, the audit requirement for weak points of
the QMS is introduced and risk management and vigilance
Section system of the manufacturer is added in the particular articles,
05.03.2020 05
11.2 which shall be audited in the re-certification assessment in line
with MDCG 2019-6 v.2.
UDFRM.84-04 MDR Software Cyrbersecurity Requirements
Checklist has been introduced in the sections 7.3 and 7.5.
In line with MDCG 2020-04 “Guidance on temporary
extraordinary measures related to medical device Notified Body
Section audits during COVID-19 quarantine orders and travel
03.06.2020 06
10.2 restrictions” the details regarding surveillance audits on
temporary extraordinary situations are introduced.
UDEM Adriatic d.o.o

UDPD.04/ 06-03.06.2020/04.01.2018/Page:49/49

28

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

28

Uploaded by

Copyright:

Available Formats

MEDICAL DEVICE REGULATION CERTIFICATION PROCEDURE

 General Manager (GM)

UDEM Adriatic d.o.o

-Harmonized Standards and Common Specification(s)

-Other guidance documents published by EC about the implementation of MDR

5. PROCUREMENT OF THE PRE-APPLICATION and APPLICATION PROCESS

5.1 Receipt of Pre-Application

5.1.1. Pre-Application Documents:

*UDFRM.04-01 contains the description of the application procedure by which

UDEM Adriatic d.o.o

5.1.2. Commitment to Be Taken During Pre-Application and Contract

1) Degradation or deviation of properties of the medical device and / or performance,

5.2. Pre-Application and Application Review Process:

5.2.1.1 Review of Pre-Application

 Verify the respective classification(s) of the product(s) in accordance with UDTLM. 19

5.2.1.2 Conformity Assessment Control Method During the Pre-Application Review

UDEM Adriatic d.o.o

1- Manufacturers of class III devices, other than custom-made or investigational devices,

1- Manufacturers of class IIa devices, other than custom-made or investigational

subparagraph, manufacturers of class III custom-made implantable devices can apply

5.2.1.3 Issuing offer for the potential Client:

5.2.2. Application Process:

5.2.2.1. Issuing the contract for the Client

 Technical Documentation set out in Annex II and III of MDR

5.2.2.2. Nomination of the Project Leader

5.2.2.3. Application Review process

 Verify the respective classifications of the applied product(s) in accordance with

 Check the of appropriate conformity assessment route is provided as specified in

 Check the availability of sufficient and appropriate resources

 Review the outsourced production processes specified by the manufacturer in the

 Review, if it is a pre-certified product, certificate and validity of previous notified

 Whether the relevant medical device is covered by another legislation is checked.

 The requirement for the consultation according Section 5 of Annex IX of MDR is

UDEM Adriatic d.o.o

6. AUDIT PLANNING PROCESS:

6.1 Appointment of Project Leader

6.2 General principals of the appointment of Personnel in different conformity

6.3 Appointment of Audit Team (Site Auditor(s))/Product Reviewers/Clinical Experts

6.4. Planning of QMS Preliminary Review Process

The audit is conducted according to UDPD.18 MDR Annex IX Conformity Assessment

6.5. Planning of QMS Site Audits

The audit is conducted according to UDPD.18 MDR Annex IX Conformity Assessment

6.6. Planning of Preliminary Technical Documentation Assessment:

UDEM Adriatic d.o.o

6.7. Planning of Technical Documentation Assessment:

Technical documentation review can be performed on desk or on-site. When it is organized

The assessment is conducted according to UDPD.18 MDR Annex IX Conformity

7. INITIAL CERTIFICATION PROCESS:

7.1. Preliminary Assessment of QMS and Technical Documentation

During initial certification process QMS documentation and Technical Documentation is

Technical documentation examination has been explained in the UDTLM.50 Technical

UDEM Adriatic d.o.o

If it is confirmed during the QMS / Technical documentation examination that conditions of

Major nonconformities or uncertainties detected during the preliminary examination

7.2. Clinical Evaluation

The clinical evaluation documentation prepared by the manufacturer is reviewed by the

7.3. Software Review

7.4. Medicinal and Absorbable Product Review

UDEM Adriatic d.o.o

Incorporating Medicinal Substance or Substances Absorbed by Human Body. The

7.5 QMS and Technical Documentation Assessments

Issues related to QMS / Technical Documentation assessment are described in UDTLM.50

The assessment reports of UDEM ADRIATIC D.O.O. include the following;

UDEM Adriatic d.o.o