Technical Documentation Checklist: Requirements of Annex II & III of EU In Vitro Medical Device Regulation 2017/746

EU IVDR:
Technical Documentation
Checklist
For In Vitro Diagnostic Device Manufacturers
Requirements of Annex II EU Medical Device Regulation 2017/745

1
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may be reproduced, stored, transmitted or used for design purposes without the prior written permission of Celegence.
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Technical Documentation Checklist: Requirements of Annex II & III of EU In Vitro Medical Device Regulation 2017/746 Technical Documentation Checklist: Requirements of Annex II & III of EU In Vitro Medical Device Regulation 2017/746

Table of Contents Table of Contents

4 Challenges The New EU IVDR Present to Medical Device Manufacturers 13 6. Product Verification And Validation (Regulation (EU) 2017/746 (IVDR),

5 Celegence Company Overview: Global Regulatory Affairs Services & Technology Annex II Section 6)

for the Life Sciences Industry 14 . Specimen Type / Handling

8 1. Device Description And Specification, Including Variants And Accessories 15 . Clinical Performance
(Regulation (EU) 2017/746 (IVDR), Annex II Section 1) 15 . Performance of Self-Testing Devices / Near-Patient Testing Devices
8 . Product or Trade Name 15 . Scientific Validity
8 . Intended Purpose, Intended User & General Device Description 16 . Performance Evaluation Report
9 . Qualification of the Product as a Device 16 . Stability (Regulation (EU) 2017/746 (IVDR), Annex II Section 6.3)
9 . Classification/Risk Class of the Device 16 . Software Verification & Validation / Functional Safety / Cyber-Securi-
9 . Configurations & Variants of the Device ty (Regulation (EU) 2017/746 (IVDR), Annex II Section 6.4)
10 . Composition of the Device 16 . Chemical Physical & Biological Properties (Regulation (EU) 2017/746
10 . Principle of Action (IVDR), Annex II Section 6.5)
17
10 . Accessories & Device Combinations • Constructional Safety

18
10 . Accessories/Equipment Required for Use but not Provided with the Devices 7. Summary of Safety and Performance (SSP) (only class C and D devic-
es) (Regulation (EU) 2017/746 (IVDR), Article 29)
10 . Reference to Previous & Similar Generaltions of the Device
19 8. Post-Market Surveillance (Regulation (EU) 2017/746 (IVDR), Annex III)
11 2. Information Supplied By The Manufacturer (Regulation (EU)) 2017/746 (IVDR),

Annex II Section 2)
20 . Post-Market Surveillance Plan

11 3. Design & Manufacturing Information (Regulation (EU) 2017/746 (IVDR), Annex II

20 . Post-Market Performance Follow-Up

Section 3) 20 9. Proposed Perimeters for Products Verification Program (only class D

11 . Design Information devices)

11 . Manufacturing Information

12 4. General Safety And Performance Requirements (Regulation (EU) 2017/746

(IVDR), Annex II Section 4)

13 5. Benefit-Risk Analysis And Risk Management (Regulation (EU) 2017/746 (IVDR,

Annex II Section 5)

2 3
The information contained in this document is the proprietary and exclusive property of Celegence except as otherwise indicated. No part of this document, in whole or in part, The information contained in this document is the proprietary and exclusive property of Celegence except as otherwise indicated. No part of this document, in whole or in part,
may be reproduced, stored, transmitted or used for design purposes without the prior written permission of Celegence. may be reproduced, stored, transmitted or used for design purposes without the prior written permission of Celegence.
©2021 Celegence. Proprietary and Confidential Document. www.celegence.com ©2021 Celegence. Proprietary and Confidential Document. www.celegence.com
Technical Documentation Checklist: Requirements of Annex II & III of EU In Vitro Medical Device Regulation 2017/746 Technical Documentation Checklist: Requirements of Annex II & III of EU In Vitro Medical Device Regulation 2017/746

Challenges The New EU IVDR Celegence Company Overview

Present to Medical Device Global Regulatory Affairs Services & Technology for the Life Sciences Industry.

Manufacturers Celegence provides expertise for every step of the Medical

Device product lifecycle management for RA, QA and
“From speaking with companies at recent Clinical Departments of Medical Device companies.
medical device conferences in the US and
EU there has been a noticeable uptick
in awareness, and concern, about the We provide support in interpreting and operationalizing apply up-to-date, robust regulatory intelligence to support
implementation of the new EU IVDR. country-specific requirements with depth and breadth product development and submission strategies.
of experience and proven processes. Our global team Benefits of our solutions and services include clear
Oftentimes changes in directives or of experts will develop the optimal regulatory strategy visibility and control over diverse product portfolios,
standards bring with it an accompanying for each In Vitro Dedical Device in your portfolio. increased operational efficience, cost reduction and
sense of a fear of change and We specialize in helping our clients reduce cost and ongoing regulatory compliance.
organisational concern at having to time to market by providing flexible, information-based Celegence provides a collaborative approach for helping
adopt new processes and recruit or services. With regulatory expertise that spans all you achieve compliance and an optimal regulatory
train new staff whilst ensuring that types of products, our global regulatory consultants strategy.
manufacturing targets are still being
Sonia Veluchamy
met. We understand the concerns and
CEO
challenges medical device manufactures
Celegence
face and are working with our clients to
help them successfully navigate the EU Our Global
IVDR requirements. Presence

We hope that this checklist will serve as Chicago

UNITED STATES
a useful starting point for you and your
organisation as you meet the challenges London
of the EU IVDR and if you need any help UNITED KINGDOM

in implementing or meeting the new

Bangalore
standards we are here to ensure you can INDIA

continue to deliver exceptional patient

value whilst being compliant to all
regulatory standards.“

4 5
The information contained in this document is the proprietary and exclusive property of Celegence except as otherwise indicated. No part of this document, in whole or in part, The information contained in this document is the proprietary and exclusive property of Celegence except as otherwise indicated. No part of this document, in whole or in part,
may be reproduced, stored, transmitted or used for design purposes without the prior written permission of Celegence. may be reproduced, stored, transmitted or used for design purposes without the prior written permission of Celegence.
©2021 Celegence. Proprietary and Confidential Document. www.celegence.com ©2021 Celegence. Proprietary and Confidential Document. www.celegence.com
Technical Documentation Checklist: Requirements of Annex II & III of EU In Vitro Medical Device Regulation 2017/746 Technical Documentation Checklist: Requirements of Annex II & III of EU In Vitro Medical Device Regulation 2017/746

Celegence’s medical device expertise also includes on-shore, region Celegence’s medical device expertise also includes on-shore, region
specific submission support and global regulatory consulting &
specific submission support and global regulatory consulting &
intelligence:
intelligence:

. US: Pre-Market Authorization (510(k) application process Gap Assessments

Region Specific
support), Premarket Approval (PMA), De Novo Petition, Local
Agent Services, UDI Services
. Device Classification as per IVDR (Classes A, B, C, D)

Submission Support . Europe: Technical File Preparation & Submission, CE Marking

. IVDR Readiness Audits and Mock Audits

and Approvals, PER Writing & Updating . Technical Documentation

. Emerging Countries: Country-Specific Submissions. . QMS development and implementation

Global Registrations
. Interpretations of local requirements including In Vitro Medical
Device Classifications, licensing, registrations and renewals . UDI and Labeling Requirements
Global Regulatory . Provide reports on country-specific updates to Regulatory . Technical File Creation
Consulting & requirements . Submission and Review
Intelligence
. Regulatory strategy consulting . CE-Marking and International

. EU MDR consulting.

Medical Writing

Celegence is a global life science consulting firm focused solely on . Performance Evaluation Plan (PEP)
regulatory and quality compliance. . Performance Evaluation Report (PER)
We have the expertise to provide support for all of your In Vitro Diagnostic . Scientific Validity Report (SVR)
(IVD) regulatory needs; from strategic consulting, registration, device . Analytical Performance Report (APR)
classification, PERs, to in country representation. . Clinical Performance Report (CPR)
. Post-Market Performance Follow-Up Plan (PMPF)

6 7
The information contained in this document is the proprietary and exclusive property of Celegence except as otherwise indicated. No part of this document, in whole or in part, The information contained in this document is the proprietary and exclusive property of Celegence except as otherwise indicated. No part of this document, in whole or in part,
may be reproduced, stored, transmitted or used for design purposes without the prior written permission of Celegence. may be reproduced, stored, transmitted or used for design purposes without the prior written permission of Celegence.
©2021 Celegence. Proprietary and Confidential Document. www.celegence.com ©2021 Celegence. Proprietary and Confidential Document. www.celegence.com
Technical Documentation Checklist: Requirements of Annex II & III of EU In Vitro Medical Device Regulation 2017/746 Technical Documentation Checklist: Requirements of Annex II & III of EU In Vitro Medical Device Regulation 2017/746

No. Requirement/Details Guidance Text Available? Comments

Technical Documentation Checklist . whether it is automated or not.

The technical file of a medical device details information about the intended
. whether it is qualitative, semi-quantitative or
quantitative.

use, safety, function, design, manufacturing process, composition, claims, and . the type of specimen(s) required.
. testing population.
clinical evaluation/evidence.
. Intended user of the device: what is the intended
user group of the device, such as self-testing,
near patient and laboratory professional use,
This checklist aims to provide a tool for manufacturers to healthcare professionals.

use when assembling the technical documentation as part . for CDx, the relevant target population with
associated medicinal product.
of CE marking requirements as set out in EU IVDR 2017/746
General device description:
. the description of the principle of the assay
method or the principles of operation of the
instrument.
No. Requirement/Details Guidance Text Available? Comments
. the description of the reactive ingredients
of relevant components such as antibodies,
antigens, nucleic acid.
1 Device
In this section, the intended purpose of
. primers; and where applicable:
. the description of the specimen collection and
the device and its intended users shall be
description and described. As well as, the principle of the
specification, assay, components, specimen collection, transport materials provided with the device or
including descriptions of.
. specifications recommended for use.
transport materials, instruments, software
variants and and accessories intended to be used with
accessories the device. The UDI-DI of the device, its risk . for instruments of automated assays: the
class, its variants, and all previous/similar description of the appropriate assay characteristics
(Regulation (EU) device generations shall be also referenced or dedicated assays.
2017/746 (IVDR), in this section. . for automated assays: a description of the
Annex II Section 1) appropriate instrumentation characteristics or
Product or trade name
dedicated instrumentation.
The product name shall be consistent with the
product displayed on the product’s packaging and . a description of any software to be used with
marketing brochures as well as the application. the device.

Basic unique device identifier Qualification of the product as a device

The Basic UDI device identifier attributed by Rationale for the qualification of the product as an In
the manufacturer to the device in question, Vitro Diagnostic medical device.
as soon as identification of this device shall
be based on a UDI system, or otherwise clear Classification / risk class of the device
identification by means of product code, The rule(s) used for classification including the
catalogue number or other unambiguous bullet point of classification rule shall be named, a
reference allowing traceability. justification shall be given.
Intended purpose, intended user and general
Configurations and variants of the device
device description.
If there are any configurations and variants of the
Intended purpose of the device:
. what is to be detected and/or measured. device, this shall be laid down in the Technical
Documentation, including any model numbers,
. its function such as screening, monitoring, names, constituents, sizes etc.
diagnosis or aid to diagnosis, prognosis,
prediction, companion diagnostic.

8 9
The information contained in this document is the proprietary and exclusive property of Celegence except as otherwise indicated. No part of this document, in whole or in part, The information contained in this document is the proprietary and exclusive property of Celegence except as otherwise indicated. No part of this document, in whole or in part,
may be reproduced, stored, transmitted or used for design purposes without the prior written permission of Celegence. may be reproduced, stored, transmitted or used for design purposes without the prior written permission of Celegence.
©2021 Celegence. Proprietary and Confidential Document. www.celegence.com ©2021 Celegence. Proprietary and Confidential Document. www.celegence.com
Technical Documentation Checklist: Requirements of Annex II & III of EU In Vitro Medical Device Regulation 2017/746 Technical Documentation Checklist: Requirements of Annex II & III of EU In Vitro Medical Device Regulation 2017/746

No. Requirement/Details Guidance Text Available? Comments No. Requirement/Details Guidance Text Available? Comments

The label or labels on the device and on its

Composition of the device 2 Information
packaging, such as single unit packaging,
All components and ingredients of the device shall supplied by the sales packaging, transport packaging in the
be shown, including, if applicable, CAS numbers, manufacturer case of specific management conditions, in
concentrations etc. the languages accepted in the Member States
(Regulation (EU) where the device is envisaged to be sold. The
Principle of action 2017/746 (IVDR), instructions for use in the languages accepted in
What is the principle of action of the device. The Annex II Section 2) the Member States where the device is
description should be specific enough to allow the envisaged to be sold.
user to understand the functioning of the device.

Accessories and device combinations In this chapter, you shall specify a description
A description of all accessories, other medical
3 Design and
of the critical ingredients, major subsystems
devices and other products (generic, batteries, manufacturing (for instruments), and algorithms (for soft-
covers, bags…) that are not medical devices, which information ware), as well as an overview of the system
are intended to be used in combination with it. (for instruments and software) pertaining to
(Regulation (EU) the device. Additionally, information to allow
If the device is to be connected to other device(s) 2017/746 (IVDR), Annex the entire manufacturing processes and
in order to operate as intended, a description of this II Section 3) identification of all production sites shall be
combination/ configuration including proof that it also specified here (procedures, process flow
conforms to the general safety and performance diagram, manufacturing configuration, etc.).
requirements when connected to any such device(s)
having regard to the characteristics specified by the
Design Information
manufacturer.
Information to allow the design stages applied
Accessories provided separately need to have their to the device to be understood.
own labelling, instruction for use, packaging and Information on the specific design stages, the
certification. techniques that are used to control, monitor
and verify the design of the device during these
stages.
Accessories / equipment required for use but not
A summary on the design process with reference
provided with the devices.
to the applied implemented documented
A description of all accessories / equipment that is procedure(s) and versions date shall be included.
required for use, but not provided with the device. For CDx, the design with regards to suitability of
Must also be mentioned in the IFU. the device in relation to the medicinal product
concerned.
Reference to previous and similar Generations of the
Device
Manufacturing Information
An overview of the previous generation or generations Manufacturing includes production, assembly,
of the device produced by the manufacturer, where packaging, sterile packaging, sterilisation, final
such devices exist; An overview of identified similar packaging (as applicable).
devices available on the Union or international markets,
where such devices exist. Flow Chart including operation steps, time
points of in-process controls (monitoring) and
final controls, reference of manufacturing
procedures (ID numbers sufficient for
traceability). A summary of manufacturing
processes allowing an understanding of the
critical process steps and utilities and process
chemical required to product the device.

10 11
The information contained in this document is the proprietary and exclusive property of Celegence except as otherwise indicated. No part of this document, in whole or in part, The information contained in this document is the proprietary and exclusive property of Celegence except as otherwise indicated. No part of this document, in whole or in part,
may be reproduced, stored, transmitted or used for design purposes without the prior written permission of Celegence. may be reproduced, stored, transmitted or used for design purposes without the prior written permission of Celegence.
©2021 Celegence. Proprietary and Confidential Document. www.celegence.com ©2021 Celegence. Proprietary and Confidential Document. www.celegence.com
Technical Documentation Checklist: Requirements of Annex II & III of EU In Vitro Medical Device Regulation 2017/746 Technical Documentation Checklist: Requirements of Annex II & III of EU In Vitro Medical Device Regulation 2017/746

No. Requirement/Details Guidance Text Available? Comments No. Requirement/Details Guidance Text Available? Comments

In case of sub-contracted (outsourced) processes: 5 Benefit-Risk All relevant risk management files according to
the current state of the art, including at minimum
. For non-critical component suppliers (e.g. bulk) Analysis and
Risk
a plan and report. If the plan and report are not
identification of supplier only. self-explanatory, a copy of the relevant risk
Management
. For critical component suppliers (e.g. outsourced (Regulation (EU)
management procedure(s) should be provided.

manufacturing of sterile device) overview of Specific Usability Risks (only for Self-Testing /
manufacturing processes and corresponding 2017/746 (IVDR),
Near-Patient Testing)
control measures (e.g. references to verification Annex II Section 5)
The risk files should specifically address risks with
and validation activities, copy of the certificate regards to usability related to self-testing or near-pa-
shall be included). tient testing. All known and foreseeable hazards
associated with layman / near-patient use must be
identified.

4 General Safety Fulfilment of all applicable General Safety and All risks associated with these hazards occurring
and Performance Requirements must be shown. If this is during intended use and during reasonable foresee-
done by a GSPR checklist, please make sure: ably misuse must be estimated and evaluated.
Performance
Requirements Non-applicable General Safety and Performance
Requirements shall have a justification as to why Risk control measures related to use error conform
(Regulation (EU) they are not applicable to the device. to safety principles, taking account of the generally
2017/746 (IVDR), acknowledged state of the art. Risks related to the er-
The evidence of conformity with the Annex I of the gonomic features of the device and the environment
Annex II Section 4)) IVDR shall be placed in this chapter. The GSPR in which the device is intended to be used must be
checklist used should contain different columns: reduced as far as possible.
(1) the requirement, (2) its applicability status, (3) The technical knowledge, experience, education,
the method(s) used to demonstrate conformity training and use environment must be considered.
with the requirement, (3) the standard(s) applied, The medical and physical conditions of intended
(4) the controlled documents offering evidence of users must be considered.
conformity.
Note: In Europe, the ISO 14971 specifies a process for a manufactur-
Demonstration of conformity includes a precise er to identify the hazards associated with medical devices. This ISO
identity of the controlled documents offering norm is recognized by the U.S. FDA.

evidence of conformity with harmonised standards,

common specification or other method employed to
demonstrate conformity with the General Safety and
6 Product This chapter shall contain the results and critical
Performance Requirements. A cross-reference to the analyses of all verifications and validation tests and/
location of such evidence is provided.
Verification
or studies undertaken to demonstrate conformity of
and Validation the device with the requirements of the IVDR and in
particular the one mentioned in the Annex I of the IVDR
(Regulation (EU)
– General Safety and Performance Requirements. Three
2017/746 (IVDR), major things shall be referenced in this chapter:
Annex II Section 6)
The Clinical Evidences of the device, including a
Performance Evaluation Plan and a Performance
Evaluation Report (Analytical Performance Report,
Clinical Performance Report, Scientific Validity
Report).

The Stability Studies of the device, including a Stability

Studies Protocol + Report.

12 13
The information contained in this document is the proprietary and exclusive property of Celegence except as otherwise indicated. No part of this document, in whole or in part, The information contained in this document is the proprietary and exclusive property of Celegence except as otherwise indicated. No part of this document, in whole or in part,
may be reproduced, stored, transmitted or used for design purposes without the prior written permission of Celegence. may be reproduced, stored, transmitted or used for design purposes without the prior written permission of Celegence.
©2021 Celegence. Proprietary and Confidential Document. www.celegence.com ©2021 Celegence. Proprietary and Confidential Document. www.celegence.com
Technical Documentation Checklist: Requirements of Annex II & III of EU In Vitro Medical Device Regulation 2017/746 Technical Documentation Checklist: Requirements of Annex II & III of EU In Vitro Medical Device Regulation 2017/746

No. Requirement/Details Guidance Text Available? Comments No. Requirement/Details Guidance Text Available? Comments

The Software Validation Evidences (if necessary), Including description of study design, populations
including a Software Validation Protocol + Report. studies, method / mode of specimen characterisa-
Note: All verification and validation documents in the sections tion, statistical methods.
below shall at a minimum comprise a plan, including acceptance
criteria and a rationale for sample size, and a report that analyses
and summarised the results. The results should be summarised in the analytical
performance report. It shall contain a conclusion if
Specimen Type / Handling the Safety and Performance requirements (including
A description of specimen type and handling, Common Technical Specifications / Common Spec-
including, where applicable: ifications) concerning the sensitivity and specificity
. Different specimen types that can be analysed are fulfilled. It shall demonstrate the analytical per-

. Determination of appropriate criteria for spec- formance, taking into consideration the state of the
art (e.g. CE-marked reference test applied).
imen collection and handling, stability, stor-
age,transport
. Usage of different anticoagulants (EDTA, Citrate, Clinical Performance
The clinical performance must be demonstrated
Heparin, etc.)
. The influence of sample pretreatment
based on:

. The influence of sample storage and freeze and . Clinical performance studies and/or
. Scientific (peer-reviewed) literature and/or
thaw cycles
. Published experience gained by routine diagnos-
Analytical Performance tic testing
The analytical performance shall contain at a
If Clinical Performance Studies are performed, a
minimum, where applicable:
. Accuracy and precision of measurement Clinical Performance Study Plan and Report shall be

. The intra- and inter-assay-precision. The sam- provided. The report shall include, where applicable:
. Diagnostic sensitivity
ples should be representative and cover different
levels of reactivity. . Diagnostic specificity
. Analytical sensitivity . Positive predictive value
. Specimen type, number of replicates, concen- . Negative predictive value
tration tested, calculation of determination of . Likelihood ratio
sensitivity should be clear.
. Analytical specificity . Expected values in normal and affected popula-
tions

Interfering endogenous / exogenous substances Performance of self-testing devices / Near-patient

investigated:
.
testing devices
Substances used for patient treatment (e.g. Layperson studies/near-patient studies shall
medicinal products)
.
demonstrate the performance for the intended user
Substances ingested by patient (e.g. alcohol, food)
.
population, taking into consideration the skills and
Substances added during specimen preparation means available to users, the environment, errors
(e.g. preservatives, stabilisers)
.
related to handling of device / specimen and
Substances encountered in specific specimen interpretation of results.
types (e.g. hemoglobin, lipids, bilirubin, proteins)
. Analytes of similar structure (e.g. precursors, Scientific Validity
metabolites)
.
Scientific validity shall be demonstrated and
Typical interfering substances documented in the scientific validity report
. Metrological traceability of calibrator and control Scientific validity demonstrated based on:

.
material values
Measuring range of the assay
. Relevant information of devices measuring the
. Limits of detection and quantitation
same analyte or marker and/or
. Scientific (peer-reviewed) literature and/or
. Measuring range (including high dose hook
. Consensus expert opinions / positions from
effect)
. Linearity relevant professional associations and/or
. Definition of assay cut-off . Results from proof-of-concept studies and/or
14 15
The information contained in this document is the proprietary and exclusive property of Celegence except as otherwise indicated. No part of this document, in whole or in part, The information contained in this document is the proprietary and exclusive property of Celegence except as otherwise indicated. No part of this document, in whole or in part,
may be reproduced, stored, transmitted or used for design purposes without the prior written permission of Celegence. may be reproduced, stored, transmitted or used for design purposes without the prior written permission of Celegence.
©2021 Celegence. Proprietary and Confidential Document. www.celegence.com ©2021 Celegence. Proprietary and Confidential Document. www.celegence.com
Technical Documentation Checklist: Requirements of Annex II & III of EU In Vitro Medical Device Regulation 2017/746 Technical Documentation Checklist: Requirements of Annex II & III of EU In Vitro Medical Device Regulation 2017/746

No. Requirement/Details Guidance Text Available? Comments No. Requirement/Details Guidance Text Available? Comments

Performance Evaluation Report Substances of Animal / Human / Microbiological

An overall Performance Evaluation Report shall Origin
summarise all performance evaluation results and A documentation of all substance of Animal /
shall contain at a minimum, where applicable: Human / Microbiological Origin. What component
. Justification for the approach taken to gather is affected, what control measures are performed.
A validation should be available, if applicable.
clinical evidence.
. Literature search methodology / protocol / report Any risks should be addressed in risk management.
of literature review (or a reference to it).
. Technology on which the device is based, the Sterile Devices or Devices with Defined
Microbiological Condition
intended purpose of the device and any claims
made about the device’s performance and/or In the case of devices placed on the market in
safety. a sterile or defined microbiological condition, a
. Scientific validity and analytical / clinical perfor- description of the environmental conditions for the
relevant manufacturing steps.
mance.
. Clinical evidence demonstrating the state-of-the- In the case of devices placed on the market in a
sterile condition, a description of the methods used,
art of the device
. New conclusions derived from Post-Market including the validation reports, with respect to
packaging, sterilisation and maintenance of sterility.
Performance Follow-Up (PMPF).
The validation report shall address bioburden testing,
Stability (Regulation (EU) 2017/746 (IVDR), Annex II and, if applicable, testing for sterilant residues.
Section 6.3) CONSTRUCTIONAL SAFETY
Demonstration of the claimed stability by appropriate
Mechanical Safety
studies, including plan(s) with predefined acceptance
A documentation that demonstrates that all relevant
criteria and rationale(s) for sample size. Where
appropriate: harmonised (if applicable) or state-of-the-art standards
and IVDR provisions were followed, including
Real-time stability, accelerated stability, on-board minimisation of all identified risks.
stability, open vial stability, shipping stability.
Electrical safety / electromagnetic compatibility
Software Verification and Validation / Functional A documentation that demonstrates that all relevant
Safety / Cybersecurity (Regulation (EU) 2017/746 harmonised (if applicable) or state-of-the-art standards
(IVDR), Annex II Section 6.4) and IVDR provisions were followed, including
Documents regarding validation of the software (ver- minimisation of all identified risks.
ification, validation and testing performed in-house Ionising and non-ionising radiation
and in actual user environment. Documentation A documentation that demonstrates that all relevant
should demonstrate the product was developed and harmonised (if applicable) or state-of-the-art stan-
manufactured according to state-of-the-art taking dards and IVDR provisions were followed, including
into account the principles of development life cycle, minimisation of all identified risks.
risk management, information security, verification
and validation. Environmental protection and safe disposal
A documentation that after use, the disposal of
Chemical Physical & Biological Properties product and packaging in accordance with hospital,
(Regulation (EU) 2017/746 (IVDR), Annex II Section 6.5) administrative and/ or local government policy is
safe. Precautions to be taken against any special,
Nanoparticle Technology
unusual risks related to the disposal of the device
The documentation should demonstrate that the should be included in the labelling.
nanoparticles were designed and manufactured in
such a way as to reduce as far as possible risks linked Packaging
to the size and the properties of particles used. A description of the packaging including a documen-
tation the demonstrates that packaging will not ad-
Hazardous Substances
versely affect the device characteristics and perfor-
A documentation of all hazardous substances that
mances during the shelf life of the device. Validation
are incorporated in the device, and how they are
of packaging with regards to integrity, cleanliness,
controlled and labelled. Any risks should be
and sterilisation, where applicable.
addressed in risk management.

16 17
The information contained in this document is the proprietary and exclusive property of Celegence except as otherwise indicated. No part of this document, in whole or in part, The information contained in this document is the proprietary and exclusive property of Celegence except as otherwise indicated. No part of this document, in whole or in part,
may be reproduced, stored, transmitted or used for design purposes without the prior written permission of Celegence. may be reproduced, stored, transmitted or used for design purposes without the prior written permission of Celegence.
©2021 Celegence. Proprietary and Confidential Document. www.celegence.com ©2021 Celegence. Proprietary and Confidential Document. www.celegence.com
Technical Documentation Checklist: Requirements of Annex II & III of EU In Vitro Medical Device Regulation 2017/746 Technical Documentation Checklist: Requirements of Annex II & III of EU In Vitro Medical Device Regulation 2017/746

No. Requirement/Details Guidance Text Available? Comments No. Requirement/Details Guidance Text Available? Comments

Devices with connection to other device(s) Post-market surveillance plan

8 Post-Market
Information how to obtain a validated and safe combi- The post-market surveillance plan shall address the
nation (including key performance characteristics).
Surveillance collection and utilisation of available information, in
particular:
A demonstration that the whole combination (in-
cluding the connection system) is safe and does
(Regulation (EU)
. information concerning serious incidents, in-
2017/746 (IVDR), cluding information from PSURs, and field safety
not impair the specified performances. Information
corrective actions,
given on known restrictions to combinations. If
device needs to be connected to other equipment,
Annex III)
. records referring to non-serious incidents and
data on any undesirable side-effects,
. information from trend reporting,
description of combination given including proof that
it conforms to the general safety and performance
requirements. . relevant specialist or technical literature, databas-
es and/or registers,
Devices with a Measuring Function . information, including feedbacks and complaints,
Measurements should be expressed in legal units provided by users, distributors and importers,and
conforming to provisions the respective regulatory . publicly-available information about similar medi-
requirements. Metrological traceability of values cal devices.
assigned to calibrators and control materials must be
shown. The post-market surveillance plan shall cover at least:
. a proactive and systematic process to collect
any information referred to above. The process

7 Summary of A summary of Safety and Performance should be shall allow a correct characterisation of the
Safety and documented. It should: performance of the devices and shall also allow a

Performance . be written in an understandable language for the comparison to be made between the device and
similar products available on the market.
(SSP) intended target group.
. include the identification of the device, including . effective and appropriate methods and processes
to assess the collected data.
(only class C
and D devices)
the basic UDI DI and the single registration num-
ber.
. suitable indicators and threshold values that shall
be used in the continuous reassessment of the
(Regulation (EU) . include the intended purpose of the device and benefit-risk analysis and of the risk management
2017/746 (IVDR), any indications, contra-indications and target as referred to in Section 3 of Annex I
Article 29) populations. . effective and appropriate methods and tools to
. include a description of the device, as well as investigate complaints and analyse market-related
experience collected in the field.
. methods and protocols to manage the events
a description of the accessories, other medical
devices and
. combination with other devices, and a reference to subject to the trend report as provided for in
Article 83, including the methods and protocols to
previous generation(s) or variants.
. include the summary of the performance eval- be used to establish any statistically significant
increase in the frequency or severity of incidents
uation report and relevant information on the as well as the observation period.
post-market production follow up. . methods and protocols to communicate effec-
. include references to harmonised standards and tively with competent authorities, notified bodies,
common (technical) specifications. economic operators and users.
. include metrological traceability of assigned . reference to procedures to fulfil the manufacturers
obligations laid down in Articles 78, 79 and 81.
. systematic procedures to identify and initiate ap-
values.
. include suggested profile and training for users.
. include information on any residual risks and any propriate measures including corrective actions.
. effective tools to trace and identify devices for
undesirable effects, warnings and precautions.
which corrective actions might be necessary.
. a PMPF plan as referred to in Part B of Annex XIII, or
a justification as to why a PMPF is not applicable.

18 19
The information contained in this document is the proprietary and exclusive property of Celegence except as otherwise indicated. No part of this document, in whole or in part, The information contained in this document is the proprietary and exclusive property of Celegence except as otherwise indicated. No part of this document, in whole or in part,
may be reproduced, stored, transmitted or used for design purposes without the prior written permission of Celegence. may be reproduced, stored, transmitted or used for design purposes without the prior written permission of Celegence.
©2021 Celegence. Proprietary and Confidential Document. www.celegence.com ©2021 Celegence. Proprietary and Confidential Document. www.celegence.com
Technical Documentation Checklist: Requirements of Annex II & III of EU In Vitro Medical Device Regulation 2017/746 Technical Documentation Checklist: Requirements of Annex II & III of EU In Vitro Medical Device Regulation 2017/746

No. Requirement/Details Guidance Text Available? Comments

Periodic Safety Update Report (PSUR) (only class C

and D devices)
The results and conclusions of the analyses of the
gathered post-market surveillance data according to

Helping You With The

Annex III together with a rationale and description of
any preventive and corrective actions taken shall be
gathered in a PSUR, all PSURs are part of the Techni-

New EU IVDR
cal Documentation.
Throughout the lifetime of the device concerned this
report shall set out:
. the conclusion of the benefit risk determination.
. the main findings of the Post Market Performance
Follow-up Report and
Challenges
. the volume of sales of devices and an estimate of
the population that use the device. Celegence has a wealth of knowledge to help you
. and, where practicable, the usage frequency of the navigate through the complex regulatory
device.

challenges that the new EU IVDR bring.

Manufacturers of class C and D devices shall update
the report at least annually and it shall be part of the
technical documentation as specified in Annexes II We can assist you throughout the entire
and III.
process to ensure that you and your business are
Post Market Performance Follow-Up (PMPF)
PMPF Evaluation reports analysing and concluding compliant with all of the EU IVDR requirements.
results of activities performed according to the PMPF
plan shall be part of the Technical Documentation.
It should include. at least items according to Annex For more information, reach out to us at
XIII part B 5.2. Conclusions of the PMPF evaluation
reports shall be taken into account for the perfor- info@celegence.com
mance evaluation and in the risk management.
Performance evaluation report shall be updated as or contact us online at
per the PMPF plan.
celegence.com

Proposed Description of the final Quality Control release testing

9 Perimeters protocol (specification of samples / panels used,
for Products final release criteria). The information must match
with the document provided to the Notified Body with
Verification
the request to release the respective batch of class D
Program product.
(only class D
devices)

20 21
The information contained in this document is the proprietary and exclusive property of Celegence except as otherwise indicated. No part of this document, in whole or in part, The information contained in this document is the proprietary and exclusive property of Celegence except as otherwise indicated. No part of this document, in whole or in part,
may be reproduced, stored, transmitted or used for design purposes without the prior written permission of Celegence. may be reproduced, stored, transmitted or used for design purposes without the prior written permission of Celegence.
©2021 Celegence. Proprietary and Confidential Document. www.celegence.com ©2021 Celegence. Proprietary and Confidential Document. www.celegence.com