Fisa Tehnica Masca de Unica Folosinta - Tip I

Documentation no.
BL/CE-01
Zhejiang Bangli Medical Products Co.,Ltd.
Technical Documentation MDR
Disposable masks, Type I Date: 2020-04-01 Rev. A/0
Regulation (EU) 2017/745
Annex II Technical Documentation

&
Annex III Technical Documentation on Post-Market Surveillance
MDR Technical Documentation for
Disposable masks, Type I

（Non sterile）
Identifier No.: BL/CE-01
Ver. A/0
Author:
Approver:
Issued Date: 2020-04-01
Manufacturer:
Address: No.118 Yuegui South Road , City West New District, 321300
Yongkang City, Zhejiang Province, China
Documentation no. BL/CE-01
Revision history
Version No. Issued date Description of Document Change
A/0 2020-04-01 Initial version

Table of Contents
• Part A ............................................................................................................................................. 5
1. General Information ................................................................................................................. 5
1.1. Legal Manufacturer .......................................................................................................... 5
1.2. Design and Manufacturing Site ....................................................................................... 5
1.3. European Authorized Representative ............................................................................. 5
1.4. Conformity Assessment Procedure ................................................................................. 5
1.5. Notified Body ..................................................................................................................... 5
1.6. Declaration that no other Notified Body is used ............................................................ 5
1.7. Definition ........................................................................................................................... 6
2. Product Information ................................................................................................................. 9
2.1. Product Name and Trade Name ...................................................................................... 9
2.2. Product Description .......................................................................................................... 9
2.3. Intended Purpose and Indication .................................................................................. 10
2.4. Functional Description ................................................................................................... 11
2.5. Type, Model, Configurations and Variants .................................................................. 12
2.6. Product Schematic Diagram .......................................................................................... 13
2.7. Product Photo .................................................................................................................. 13
2.8. Classification ................................................................................................................... 14
2.9. Device Subcategory ......................................................................................................... 14
2.10. Generic Device Group ................................................................................................ 14
2.11. Basic UDI-DI or Product Code .................................................................................. 14
2.12. Brochures and Catalogues.......................................................................................... 14
2.13. Product Combinations and Accessories .................................................................... 14
2.14. Similar and Previous Generations of the Device ...................................................... 15
2.15. Bill of Material and Drawings.................................................................................... 15
2.16. Product Performances and Safety Specification ...................................................... 16
2.17. Shelf-Life or Lifetime.................................................................................................. 17
3. Labelling .................................................................................................................................. 18
4. Instructions for Use................................................................................................................. 19
5. Design and Manufacturing Information ............................................................................... 20
6. General Safety and Performance Requirements .................................................................. 21
7. Applied Standards .................................................................................................................. 22
8. Product Verification and Validation ..................................................................................... 23
8.1. Pre-Clinical Evaluation .................................................................................................. 23
8.2. Product Testing (Performance and Safety) .................................................................. 23

8.3. Biocompatibility Evaluation........................................................................................... 24
8.4. Package ............................................................................................................................ 25
8.5. Transportation Evaluation ............................................................................................. 26
8.6. Sterilization Validation ................................................................................................... 26
8.7. Stability and Shelf Life ................................................................................................... 26
8.8. Usability Engineering ..................................................................................................... 27
9. Risk Management ................................................................................................................... 27
10. Clinical Evaluation.............................................................................................................. 29
11. EU Declaration of Conformity ........................................................................................... 30
12. Technical Documentation on Post-Market Surveillance ................................................. 32
12.1 Post-market Surveillance Plan and Report ...................................................................... 32
12.2 Periodic Safety Update Report (PSUR) ............................................................................ 33
12.3 Post-Market Clinical Follow-Up ........................................................................................ 33
13 Documentation and Reporting of Design Changes .......................................................... 35
• Part B ........................................................................................................................................... 36
- Appendix 1.3: European Authorized Representative Agreement ............................................. 36
- Appendix 2.1: Drawings and Specification .............................................................................. 36
- Appendix 3.1: Product Labelling .............................................................................................. 36
- Appendix 4.1: Instructions for Use ........................................................................................... 36
- Appendix 5.1: Design and Manufacturing ................................................................................ 36
- Appendix 6.1: General Safety and Performance Requirements Check List ............................. 36
- Appendix 8.1: Type Examination Report ................................................................................. 36
- Appendix 8.2: Biocompatibility Testing Report ....................................................................... 36
- Appendix 8.3: Stability and Transport Validation Report ........................................................ 36
- Appendix 8.4: Usability Engineering Files ............................................................................... 36
- Appendix 9.1: Risk Management Plan and Report ................................................................... 36
- Appendix 10.1: Clinical Evaluation File .................................................................................. 36
- Appendix 11.1: EU Declaration of Conformity........................................................................ 36
- Appendix 12.1: Post Market Surveillance File ......................................................................... 36
Part A
1. General Information
1.1. Legal Manufacturer

Name: Zhejiang Bangli Medical Products Co.,Ltd.
Address: No.118 Yuegui South Road , City West New District, 321300 Yongkang City,
Zhejiang Province, China
1.2. Design and Manufacturing Site

Name: Zhejiang Bangli Medical Products Co.,Ltd.
Address: No.118 Yuegui South Road , City West New District, 321300 Yongkang City,
Zhejiang Province, China
1.3. European Authorized Representative

Name: MedPath GmbH
Address: Mies-van-der-Rohe-Strasse 8, 80807 Munich, Germany

DIMDI
DE/0000047823
Code:
MDD
Appendix 1.3: European Authorized Representative agreement.
agreement:
1.4. Conformity Assessment Procedure

According to Regulation (EU) 2017/745 Article 52, the manufacturer follows the conformity
assessment procedure relating to the EU declaration of conformity referred to in Article 19
after drawing up the technical documentation set out in Annexes II and III.
1.5. Notified Body

No involvement of a Notified Body is needed for this class I device.
1.6. Declaration that no other Notified Body is used

Not applicable. No involvement of a Notified Body is needed for this class I device.
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1.7. Definition
• Medical device means any instrument, apparatus, appliance, software, implant, reagent,
material or other article intended by the manufacturer to be used, alone or in combination,
for human beings for one or more of the following specific medical purposes:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
- investigation, replacement or modification of the anatomy or of a physiological or
pathological process or state,
- providing information by means of in vitro examination of specimens derived from the
human body, including organ, blood and tissue donations,
and which does not achieve its principal intended action by pharmacological,
immunological or metabolic means, in or on the human body, but which may be assisted
in its function by such means.
The following products shall also be deemed to be medical devices:
- devices for the control or support of conception;
- products specifically intended for the cleaning, disinfection or sterilisation of devices
as referred to in Article 1(4) and of those referred to in the first paragraph of this point.
• Accessory for a medical device means an article which, whilst not being itself a
medical device, is intended by its manufacturer to be used together with one or several
particular medical device(s) to specifically enable the medical device(s) to be used in
accordance with its/their intended purpose(s) or to specifically and directly assist the
medical functionality of the medical device(s) in terms of its/their intended purpose(s).
• Single-use device means a device that is intended to be used on one individual during a
single procedure.
• Intended purpose means the use for which a device is intended according to the data
supplied by the manufacturer on the label, in the instructions for use or in promotional or
sales materials or statements and as specified by the manufacturer in the clinical
evaluation.
• Unique Device Identifier (‘UDI’) means a series of numeric or alphanumeric characters
that is created through internationally accepted device identification and coding
standards and that allows unambiguous identification of specific devices on the market
• Manufacturer means a natural or legal person who manufactures or fully refurbishes a
device or has a device designed, manufactured or fully refurbished, and markets that
device under its name or trademark.
• Authorised representative means any natural or legal person established within the
Union who has received and accepted a written mandate from a manufacturer, located
outside the Union, to act on the manufacturer's behalf in relation to specified tasks with
regard to the latter's obligations under this Regulation.
• Importer means any natural or legal person established within the Union that places a
device from a third country on the Union market.
• Distributor means any natural or legal person in the supply chain, other than the
manufacturer or the importer, that makes a device available on the market, up until the
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point of putting into service.

• Economic operator means a manufacturer, an authorised representative, an importer, a
distributor or the person referred to in MDR Article 22(1) and 22(3).
• User means any healthcare professional or lay person who uses a device.
• CE marking of conformity or CE marking means a marking by which a manufacturer
indicates that a device is in conformity with the applicable requirements set out in this
Regulation and other applicable Union harmonisation legislation providing for its
affixing.
• Technical Documentation: The complete compilation of documentation demonstrating
that products placed on the market conform to the requirements specified in the Medical
Device Regulation (EU) 2017/745 and other related regulatory requirements.
• Risk Assessment: An analysis which identifies and investigates potential risks,
determines if they are hazardous and require mitigation, and identifies how such risks are
to be eliminated or reduced.
• Substantial / Significant Change: Changes to the Quality System, Design of a Device
or Technical File which affect compliance with the requirements of the relevant
Regulations/Directive(s), shall be communicated to the Notified Body and the
Authorized Representative.
• Harmonised standard means a European standard as defined in point (1)(c) of Article 2
of Regulation (EU) No 1025/2012
• Common specifications (CS) means a set of technical and/or clinical requirements,
other than a standard, that provides a means of complying with the legal obligations
applicable to a device, process or system.
• Incident means any malfunction or deterioration in the characteristics or performance of
a device made available on the market, including use-error due to ergonomic features, as
well as any inadequacy in the information supplied by the manufacturer and any
undesirable side-effect.
• Post-market surveillance means all activities carried out by manufacturers in
cooperation with other economic operators to institute and keep up to date a systematic
procedure to proactively collect and review experience gained from devices they place
on the market, make available on the market or put into service for the purpose of
identifying any need to immediately apply any necessary corrective or preventive
actions.
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Annex II Technical Documentation
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2. Product Information
2.1. Product Name and Trade Name

Name: Disposable masks
Type: Flat ear loop YA-FM

Size: 17.5×9.5 cm
2.2. Product Description

Disposable mask is a medical device covering the mouth and nose providing a barrier to
minimize the direct transmission of infective agents between staff and patient.
The transmission of infective agents during medical procedures can occur in several ways.
Sources are e.g. noses and mouths of the medical team. The main intended use of Disposable
masks is to protect the patients from infective agents. Disposable masks may also be
intended to be worn by patients and other persons to reduce the risk of spread of infections,
particularly in epidemic or pandemic situations.
These product meets the requirements of European Standard EN 14683:2019, Disposable
masks– requirements and test methods. It is used to limit the transmission of infective agents
exhaled by the wearer to the environment and patients. It also provides additional protection
against the penetration of bodily fluids through the product.
The mask consists of a facepiece, two ear loops and a nose clip. The facepiece is composed
of a filter layer made of PP that is moulded between two layers of non-woven fabric.
This three-ply material is made up from a melt-blown material PP placed between non-
woven fabric. The melt-blown material PP acts as the filter that stops microbes from entering
or exiting the mask. The masks feature pleats or folds. Three pleats are used to allow the user
to expand the mask such that it covers the area from the nose to the chin.
The mask is secured by the elastic ear loop, where a string-like material is attached to the
mask and placed behind the ears.
The Disposable masks are developed according to ergonomic criteria offers the right solution
for every face type and for every application. The 3-layer construction provides effective
protection against infections for patients and medical personnel in accordance with Type I of
EN 14683.
The inner site of the facepiece is white while the outer site is light blue. The size of the mask
are: 17.5×9.5 cm.
The elastic ear loop has a basic length of 8.0 cm.

Disposable masks are packed with 50 masks in dispenser box.
This is a single-use device. The uninterrupted use duration of the device is usually less than
8 hours.
The device is delivered in a nonsterile state. The shelf life is defined for 2 years after
Production. A re-use by users is not allowed.
Disposable masks have the following characteristics:
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- Flat-fold design provides convenient storage prior to use

- Lightweight, ear loop mask is easy to put on and remove
- It is comfortable and fits a wide range of wearers
- Effective filtration and easy breathing
- Latex free
2.3. Intended Purpose and Indication

This product meets European Standard EN 14683, Type I.
As a Disposable mask, it is intended to provide a barrier to minimize the direct transmission

of infective agents between staff and patient.
Disposable masks may also be intended to be worn by patients and other persons to reduce the
risk of spread of infections, particularly in epidemic or pandemic situations.
This is a single-use device.
Intended users
The users of the Disposable mask are medical staffs.
Disposable masks may also be intended to be worn by patients and other persons.
Size 17.5×9.5 cm is intended for adults/teens/ladies.
There are no limits in patient population and medical conditions.
Contraindications
Do not use the Disposable mask for respiratory protection for the wearer.
This mask is not suitable for surgical procedures in operating theatres.
This mask is not intended for industrial use.
Cautions and Warnings

• Inspect mask before the use to ensure that it is in good operating condition. Examine all
the mask parts for signs of damage including the two ear loops, nose clip and facepiece
material.
• Ensure there are no holes in the breathing zone and no damage has occurred.
• Avoid touching the inside of the mask with your hands.
• If you are concerned about the smell of the mask or feel it hard to breathe or feel
nauseous, please stop using immediately.
• If itching, spot rash or other symptoms occur, please stop using immediately.
• Change the mask timely. Replace the mask immediately if it is damaged or soiled,
breathing becomes difficult or contaminated with blood or body fluids.
• The mask should be disposed of immediately upon observation of damage or missing
parts.
• Dispose of used product in accordance with applicable regulations.
• This is single-use device. A reprocessing and re-use of the device is not allowed. An
infection or transmission of diseases could occur, if the device were to be re-used.
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2.4. Functional Description
Figure 1 Function Mechanism of Disposable masks
Bacterial Filtration Efficiency (BFE) measures filter performance in both directions. The less
bacteria penetrate, the higher the performance. The BFE value of ≥ 95% required by the EU
standard EN 14683 is observed by these masks.
Figure 2 Bacterial Filtration Efficiency
When breathing, speaking, coughing, sneezing etc., one releases smaller or larger amounts of
droplets of secretions from the mucous membranes in the mouth and nose. The majority of
the nuclei are between 0,5μm and 12μm in diameter and especially the larger droplets can
contain micro-organisms from the source site. Nuclei can subsequently spread through the
air to a susceptible site such as an open operating wound or sterile equipment. The
Disposable masks intended to be used in operating rooms and health care settings with
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similar requirements are designed to protect the entire working environment. The standard
describes two types of Disposable masks with associated protection levels. As a minimum,
Type I Disposable masks are used for patients in order to reduce the risk of the spread of
infections, particularly in epidemic or pandemic situations. Type II masks are principally
intended for use by healthcare professionals in an operating room or other medical settings
with similar requirements. A special case, also covered by the European Medical Devices
legislation, is that in which the wearer wishes to protect him/herself against splashes of
potentially contaminated fluids and particles that are created in the surgical environment, e.g.
by the use of electro-cautery devices. If the intended use of the mask is to protect the wearer
against infective agents (bacteria, viruses or fungi), the use of a respirator device should be
considered. Performance requirements for respirators are the scope of EN149. The level of
efficiency offered by a mask depends on a number of factors such as the filtration efficiency,
quality of the material and the fit of the mask on the wearer’s face. Different designs are
suited for different applications and the careful choice of mask is therefore important in order
to achieve the desired result. The filtration capacity of mask materials can vary depending on
the filter media. The fit of masks varies considerably from those which are held in place by
ear loops fastened behind the wearer’s ears to those with tie bands around the head and a
nose clamp that can be shaped to the wearer’s nose. The effect of a very good or less good fit
can be tested in vivo whereas the filtration efficiency may be reproducibly tested in vitro.
The considerable variations in results when masks are tested in vivo results in the need for
large groups of test subjects and observations. It is thus usual to characterise mask
performance using in vitro tests of the material from which the mask is made. It is, however,
important to consider the fit of the mask carefully when a mask for a certain application is
chosen. Users should request such information from their suppliers. A further factor to be
considered is the capacity of the mask to absorb moisture from the exhaled air and thereby to
maintain its performance over a longer period of time. The more advanced designs easily
maintain their performance throughout even very long operations whereas the less advanced
ones are intended only for short procedures. The contamination risk resulting from hand
contact with a used mask means that it is essential that the mask is taken off and disposed of
when no longer worn over nose and mouth. When there is a further need for protection then a
new mask should be put on. Touching a used face mask or putting on a new one should
always be followed by a full hand disinfection procedure and a used mask should always be
disposed of when no longer needed or between two procedures. In summary, to use an
appropriate mask is an effective means to protect the working environment from droplet
contamination from nose and throat during health care procedures. Masks with very different
performance are, however, available. Therefore such factors as infection risk and mask fit
should be carefully considered when choosing a mask.
2.5. Type, Model, Configurations and Variants

Type: Flat ear loop
Size: 17.5×9.5 cm
This product is Type I mask acc. to European Standard EN 14683.
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2.6. Product Schematic Diagram
Figure 3 Schematic Diagram of Disposable masks
2.7. Product Photo
Figure 4 Disposable masks
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2.8. Classification
According to the definition of MDD Article 2 the Disposable mask is a medical device. It is
used for prevention of disease.
Disposable masks are classified as
Class: I
Rule: 1
MDR Annex VIII:
“All non-invasive devices are classified as class I, unless one of the rules set out hereinafter
applies.”.
Justification of the classification

Disposable mask is a non-active device for single use, and is intended to be used non-
invasively. The use duration is usually less than 8 hours (short-term use).
No other rules set out in MDD Annex IX are applicable for this device.
2.9. Device Subcategory
DEVICE CODE Device subcategory
General non-active non-implantable devices used in health

MDN 1214
care and other non-active non-implantable devices
2.10.Generic Device Group

NA
2.11.Basic UDI-DI or Product Code

Not available yet
2.12.Brochures and Catalogues

As we sell no devices to end user, but only to distributors, we don’t have any brochures or
product catalogues for this device. When we issue a promotion material, we will consult our
technical department and then add technical specifications, such as features, dimensions and
performance attributes, of the device and any variants/configurations and accessories. Any
promotional material will mention that the device fulfils the requirements for CE marking.
2.13. Product Combinations and Accessories

Disposable masks may be used together with other medical instruments. No specific
combinations are required.
Accessories for a device: none.
Other devices for combination: none.
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2.14.Similar and Previous Generations of the Device

Disposable mask is a conventional device with well-established technology. There were no
previous generations of this device from our company.
For clinical evaluation of Disposable masks, similar devices “Procedure Mask” from the
manufacturer 3M were selected as example.
2.15.Bill of Material and Drawings

We purchase all materials only from approved suppliers that have satisfied the selection and
evaluation criteria as described in the SOP. These suppliers are listed in the Approved Supplier
List.
The main raw materials for Disposable mask are non-woven fabric and PP.
Material for primary packaging: dispenser box.
A detailed specification for the material used for manufacturing is described in the raw material
list. This information is used during material purchasing.
The incoming product quality of each batch of purchased material is inspected according to
the specification.
Inspection methods and purchased product verification activities are described in the SOP. The
status of acceptance is described in the SOP - Identification and Traceability. Trained and
competent personnel at site will perform incoming material verification activities.
Drawings for the Disposable masks refer to Appendix 2.1: Drawings and Specification.
Table 1 Bill of Material
Part of Mask Material
Facepiece Non-woven fabric (PP)
Facepiece inlay Melt-blown material (PP)
Ear loop Polyester + Cotton
Nose clip PVC
Packaging material Dispenser box from paper
Outer Packaging Corrugated carton
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2.16.Product Performances and Safety Specification

Disposable masks are designed, manufactured and tested acc. to the standards listed in section
7.
Safety and performance specification include:
Bacterial filtration efficiency (BFE): efficiency of the Disposable mask as a barrier to
bacterial penetration.
The BFE test method is used to measure the bacterial filtration efficiency (BFE) of Disposable
mask materials.
Microbial cleanliness: freedom from population of viable micro-organisms on a product
and/or a package.
In practical use, microbial cleanliness is often referred to as “bioburden”.
Differential pressure: air permeability of the mask, measured by determining the difference
of pressure across the mask under specific conditions of air flow, temperature and humidity.
The differential pressure is an indicator of the “breathability” of the mask.
Splash resistance: ability of a Disposable mask to withstand penetration of synthetic blood
projected at a given pressure.
Disposable masks specified in the European Standard EN 14683 are classified into two types
(Type I and Type II) according to bacterial filtration efficiency whereby Type II is further
divided according to whether or not the mask is splash resistant. The “R” signifies splash
resistance.
This Disposable mask is Type I mask acc. to EN 14683.
Technical Specifications
Materials and construction
The Disposable mask is a medical device, composed of a filter layer that is moulded between
layers of fabric. The Disposable mask shall not disintegrate, split or tear during intended use.
In the selection of the filter and layer materials, attention shall be paid to cleanliness.
Design
The Disposable mask shall have a means by which it can be fitted closely over the nose, mouth
and chin of the wearer and which ensures that the mask fits closely at the sides.
Disposable masks may have different shapes and constructions as well as additional features
such as a face shield with a nose bridge (to enhance fit by conforming to the nose contours).
Performance requirements
All tests shall be carried out on finished products or samples cut from finished products.
Bacterial filtration efficiency (BFE)
When tested in accordance with Annex B of EN 14683, the BFE of the Disposable mask shall
conform to the minimum value given for the relevant type in Table 1 of EN 14683.
Breathability
When tested in accordance with Annex C of EN 14683, the differential pressure of the
Disposable mask shall conform to the value given in relevant type in Table 1 of EN 14683.
Microbial cleanliness (Bioburden)
When tested according to EN ISO 11737-1 the bioburden of the Disposable mask ahsll be ≤
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30 cfu/g tested.
The number of masks that shall be tested is minimum 5 of the same batch/lot.
Biocompatibility
According to the definition and classification in EN ISO 10993-1, a Disposable mask is a
surface device with limited contact. An evaluation should be made for the Disposable mask
according to EN ISO 10993-1 and applicable toxicology testing regime shall be determined.
Breaking strength
The breaking strength at the connection point between each mask belt and the mask body
should be not less than 10N.
EN 14683 Table 1 — Performance requirements for Disposable masks

Test Type I Type II Type IIR
Bacterial filtration ≥ 95 ≥ 98 ≥ 98
efficiency (BFE), (%)
Differential pressure < 40 < 40 < 60
(Pa/cm2)
Splash resistance pressure Not required Not required ≥ 16,0
(kPa)
Microbial cleanliness ≤ 30 ≤ 30 ≤ 30
(cfu/g)
2.17. Shelf-Life or Lifetime

The shelf-life is 2 years after Production.
The uninterrupted use duration of the device is usually less than 8 hours.
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3. Labelling
For Disposable masks, information supplied by the manufacturer comprises the details on the
label.
As labelling on the device itself is not practicable, the information needed to use the device
safely is set out on the primary packaging and on the sales packaging (carton).
Labelling includes all applicable information required by MDR, Annex I, Chapter III, section
23.2 and EN 1041 “Information supplied by the manufacturer of medical devices”.
This information takes the form of internationally recognized symbols. The symbols used are
conform to the harmonized standard EN ISO 15223-1.
Package labeling includes product identification, lot number, product description, used by
date, manufacturing date, do not re-use, do not use if package is damaged, caution, consult
instruction for use, manufacturer and EU representative information, etc.
Information for labelling was drafted as per Appendix 3.1: Product labelling in this Technical
File.
The Organization ensures that only approved packaging labels will be used and distributed
together with the products.
Each product unit is properly packaging to ensure its packing integrity without any damages
or deterioration in nature. The production lot number and manufacturing date are identified.
The packaging and storage activities are described in the SOP Preservation of Products.
All packaging materials are properly labeled according the SOP Identification and Traceability.
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4. Instructions for Use
Instructions for Use (IFU) are provided with the medical devices together by the organization
to inform the device user or medical staff of the product’s proper use and of any precautions
to be taken.
The instructions for use are provided in accordance with MDR, Annex I, Chapter III, section
23.4, include, where appropriate, detailed informing for the users and/or patients and allowing
the medical staff to brief the patient on any contra-indications, warnings and any precautions
to be taken.
The meaning of symbols used on the label is explained in the IFU.
The “Instructions for Use” include but not limited to the contents below:
i. Product name;
ii. Description/indications;
iii. Specification;
iv. Warnings and Precautions;
v. Instruction for use;
vi. Storage conditions;
vii. Shelf life;
viii. Product disposal;
ix. Explanation of symbols used on labels and IFU;
x. Manufacturer and EC REP information;
xi. Version and issued date.
xii. CE (with notify body number, if required).
The target markets within EU are Ireland, England, Scotland and Wales with English as an
official language. Other markets and the required languages (IFU, labelling) within EU
markets will follow after other target markets confirmed.
If other languages are required by local distributors or users, we will engage a translation of
the instructions for use by a qualified translation office. The translated text will be sent to the
local distributor for checking the correctness of the translation.
Information for use of this product is described in Appendix 4.1: Instructions for Use in this
Technical File.
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5. Design and Manufacturing Information
Design and manufacturing sites refer to section 1 of the Technical Documentation. All design
and manufacturing activities are performed in house. No critical activities are outsourced.
Quality Management System has been established according to EN ISO 13485. The device
in question has been designed and developed according to EN ISO 13485, chapter 7.3 design
and development. The design and development stages included: design and development
planning, market analysis and feasibility evaluation, design and development input, review
and output, as well as verification, validation, and design transfer. Risk management has
been included throughout the design process.
The manufacturing process for the device in question is described in the manufacturing
process flowchart, refer to <Manufacturing Process Flowchart>.
Purchasing of raw material →
Incoming quality control →
Mask body forming, folding →
Welding of ear loop →
Quality control →
Packaging →
Finished device test and release.
The critical manufacturing processes, e.g. welding, quality control, fold and packaging take
place in clean room condition, classified as ISO class 8 according to ISO 14644-1.
In-process control and finished-product test are specified in the test instructions. The batch-
related test program includes bioburden test, safety and performance test, etc. The product
specification and acceptance criteria are described in section 2.16 “Product performances and
safety specification” of the Technical Documentation.
After completion of the final tests with satisfied results, the batch will be released with a batch-
release record. This record is considered as a part of declaration of conformity for the produced
batch.
The Production Order will be sent to the Production Officer and/or Production Technician in
order to prepare and production plan for the production. The raw materials specification will
also be communicated with the purchaser and the raw material and machining tooling are
purchased from the approved suppliers according to the material specifications.
Incoming inspection is carried out on every batch of incoming products according to the
SOP, IQC records are maintained by QC department.
Document procedures for traceability has been established in accordance with applicable
regulatory requirements and the records to be maintained during product life cycle.
The competence of the personnel performing the operation is identified and the production
processes are operated according to good manufacturing practices.
Steps are also taken to control product cleanliness and to avoid contamination as described in
the SOPs.
Manufacturing process flowchart and SOPs refer to Appendix 5.1: Design and
Manufacturing in this Technical File.
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6. General Safety and Performance Requirements
The devices in question meet the general safety and performance requirements set out in
Annex I of MDR that are applicable to the device taking into account its intended purpose.
Harmonized standards are used for designing and manufacturing the device to fulfil the
requirements.
The standards used and evidence of conformity with such harmonized standards are
documented in Appendix 6.1: General Safety and Performance Requirements Check
List.
The information covers the following aspects:
a) Reference to the standards used;
b) Document of procedures or reports that are used as evidence of satisfying the General
Safety and Performance Requirements;
c) Indicate whether the General Safety and Performance Requirements are applicable or
not;
d) Location where the relevant documents, procedures, work instruction or reports are
being kept.
The check list includes a justification, validation and verification of the solutions adopted to
meet those requirements. The demonstration of conformity includes:
- The general safety and performance requirements that apply to the device and an explanation
as to why others do not apply;
- The methods used to demonstrate conformity with each applicable general safety and
performance requirement;
- The harmonized standards as well as CS; and
- The precise identity of the controlled documents offering evidence of conformity with each
harmonized standard, CS or other method applied to demonstrate conformity with the general
safety and performance requirements. The information referred to under this point
incorporates a cross-reference to the location of such evidence within the full technical
documentation.
For product performance, the organization ensures that the performance of the product is
controlled by routine process quality monitoring and test as well as inspection program.
Page 21 of 36
7. Applied Standards
List of applied/harmonized standards are listed as bellowing:
EN 1041:2008 +A1:2013 Information supplied by the manufacturer of medical devices

EN ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels,
labelling and information to be supplied - Part 1: General
requirements
EN 14683:2019+AC:2019 Disposable masks - Requirements and test methods
EN ISO 10993-1:2017 Biological evaluation of medical devices - Part 1: Evaluation and
ISO 10993-1:2018 testing within a risk management process
EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro
cytotoxicity
EN ISO 10993-10:2013 Biological evaluation of medical devices - Part 10: Tests for
irritation and skin sensitization
EN ISO 11737-1:2018 Sterilization of medical devices - Microbiological methods - Part 1:
Determination of a population of microorganisms on products
EN ISO 14644-1:2015 Cleanrooms and associated controlled environments - Part 1:
Classification of air cleanliness by particle concentration
EN ISO 14644-2:2015 Cleanrooms and associated controlled environments - Part 2:
Monitoring to provide evidence of cleanroom performance related
to air cleanliness by particle concentration
EN ISO 14698-1:2003 Cleanrooms and associated controlled environments -
Biocontamination control - Part 1: General principles and methods
EN ISO 14698-2:2003 Cleanrooms and associated controlled environments -
Biocontamination control - Part 2: Evaluation and interpretation of
biocontamination data
ISO 14971:2019 Medical devices - Application of risk management to medical
EN ISO 14971:2012 devices
EN 62366-1:2015 + Medical devices - Application of usability engineering to medical
AC:2015 devices
MEDDEV 2.7/1, rev. 4: Clinical Evaluation: A guide for manufacturers and Notified Bodies
2016 under Directives 93/42/EEC and 90/385/EEC
Page 22 of 36
8. Product Verification and Validation
8.1. Pre-Clinical Evaluation

Pre-clinical evaluation was performed in framework of design validation. It includes
functional and performance testing acc. to the product specification.
The documentation contains the results and critical analyses of all verifications and validation
tests and/or studies undertaken to demonstrate conformity of the device with the requirements
of the MDR and in particular the applicable general safety and performance requirements.
The tests confirm the pre-clinical safety of the device and its conformity with the specifications.
The test results refer to section 8.2.
Other tests, e.g. Biocompatibility have also been performed, s. section 8.3.
8.2. Product Testing (Performance and Safety)

Disposable masks are designed, manufactured and tested acc. to the standard series EN
14683:2019+AC:2019. Performance, safety and functional testing has been performed in
product type examination. Test reports are included in Appendix 8.1: Type Examination
Report.
The performance and safety test includes bacterial filtration efficiency (BFE), breathability,
microbial cleanliness (Bioburden), breaking strength.
The test was conducted by the accredited laboratory with representative samples of Disposable
masks.
In addition, batch-release test is performed for each production batch including safety and
performance test and bioburden test. The product specification and acceptance criteria are
described in section 2.16 “Product performances and safety specification” of the Technical
Documentation.
Page 23 of 36
8.3. Biocompatibility Evaluation

Materials in direct or indirect contact with the patient or user are identified and specified in
bill of material. All these materials are bridely used in medical devices and have been proved
as biocompatible and safe materials.
Biocompatibility Evaluation is based on laboratory tests as defined for the product category
in table A.1 of EN ISO 10993-1.
For the Disposable masks following consideration can be taken:
Nature of body contact: Intact skin or indirect contact with mucosal membrane;
Contact duration: A — limited (≤ 24 h).
According to ISO 10993-1:2018 following tests should be done:
- Cytotoxicity acc. to EN ISO 10993-5;
- Sensitization acc. to EN ISO 10993-10;
- Irritation or intracutaneous reactivity acc. to EN ISO 10993-10.
All required tests were conducted with representative samples of Disposable masks with
satisfied results.
Cytotoxicity
In Vitro Cytotoxicity Test Report
The MTT method results showed that the cytotoxicity ration of the 100% test article extract
met the requirements. The test article extract did not show potential toxicity to L-929 cells.
Sensitization
Skin Sensitization Test Report
The positive rate of all test groups was 0%. All animals were not found abnormal clinical
symptoms except skin reactions. All animals were normal weight changed. The sample
extract chowed no signification evidence of causing skin sensitization in the guinea pig.
Irritation or intracutaneous reactivity
Skin Irritation Test Report
The response of skin on testing sites was not more severe than that on the control sites. The
primary irritation index for the test article was calculated to be 0. No abnormal clinical
symptoms except skin reactions was found for all animals. The test result showed that the
test article extract did not induce skin irritation in rabbit.
The tests were performed by the accredited laboratory.
The test reports are included in Appendix 8.2: Biocompatibility testing report.
Similar masks have been manufactured and sold since decades. There were no incidents or
serious complaints in relation to biocompatibility. This fact supports the evidence for good
biocompatibility with the products.
Evaluation of biocompatibility is a continuous process. For this purpose, post-production
experience will be gathered and analysed. As soon as there are abnormalities in use of the
Disposable masks, a new evaluation will be started.
Page 24 of 36
8.4. Package
Disposable masks are primarily packed in the dispenser box.
Each dispenser box contains 50 masks.
40 dispenser boxes are packed into a sales box (2000 masks).
The packaging process is specified in work instruction.
Figure 5 Packaging of Disposable masks
Page 25 of 36
8.5. Transportation Evaluation

Characteristics and performances of the device will not be adversely affected during
transport and storage taking account of the instructions and information provided by the
manufacturer.
Transportation simulation tests were performed with the test methods of dropping test,
shaking test, vibrating test and stacking test, s. Appendix 8.3: Stability and transport
validation report.
The test results demonstrated that the packaging system for Disposable masks is suitable and
can provide sufficient protection of devices during the transport and storage.
In addition, there were no complaint cases concerning transport damages. This confirms a
suitability of the packaging system.
8.6. Sterilization Validation

NA.
The devices are provided in nonsterile state.
8.7. Stability and Shelf Life

Shelf Life is defined for 2 years after manufacturing.
In order to validate the product stability and packaging integrity after shelf life time, an
accelerated aging test acc. to ASTM F1980 was conducted with representative product
packaging of Disposable masks. After the defined aging process, functional and performance
as well as packaging integrity could be tested with positive results.
Test protocol and report refers to Appendix 8.3: Stability and transport validation report.
Medical devices are required to be stored in the original packaging and away from
contaminated areas, dust, sunlight, extreme temperatures, excessive moisture and damaging
chemicals.
Page 26 of 36
8.8. Usability Engineering

Usability evaluation has been conducted acc. to EN 62366-1.
The Usability Report demonstrated that no use errors would be caused by inadequate
medical device usability, s. Appendix 8.4: Usability Engineering File.
Potential risks in relation to usability are discussed in the risk management. It can be
concluded that such risks are acceptable and no user training is needed for safe use of the
device. The usability engineering process provides safety for the patient, user and others
related to usability. The process addresses user interactions with the medical device
according to the accompanying document, including transport, storage, operation and
disposal of the device.
9. Risk Management
As manufacturer we establish, document and maintain throughout the entire lifecycle a

continuous iterative process for identifying hazards associated with a medical device,
estimating and evaluating the associated risks, controlling these risks, and monitoring the
effectiveness of the controls.
In carrying out risk management we:

(a) establish and document a risk management plan for each device;
(b) identify and analyse the known and foreseeable hazards associated with each device;
(c) estimate and evaluate the risks associated with, and occurring during, the intended use
and during reasonably foreseeable misuse;
(d) eliminate or control the risks in accordance with the requirements;
(e) evaluate the impact of information from the production phase and, in particular, from the
post-market surveillance system, on hazards and the frequency of occurrence thereof, on
estimates of their associated risks, as well as on the overall risk, benefit-risk ratio and risk
acceptability; and
(f) based on the evaluation of the impact of the information, if necessary amend control
measures in line with the requirements.
This process includes the following elements:
⎯ risk analysis;
⎯ risk evaluation;
⎯ risk control;
⎯ production and post-production information.
Risk Management is performed acc. to EN ISO 14971.
Risk control measures for the design and manufacture of the devices are conform to safety
principles, taking account of the generally acknowledged state of the art. To reduce risks, we
manage risks so that the residual risk associated with each hazard as well as the overall
residual risk is judged acceptable. In selecting the most appropriate solutions, we follow the
order of priority: (a) eliminate or reduce risks as far as possible through safe design and
manufacture; (b) where appropriate, take adequate protection measures, including alarms if
Page 27 of 36
necessary, in relation to risks that cannot be eliminated; and (c) provide information for
safety (warnings/precautions/contra-indications) and, where appropriate, training to users.
Risk management plan has been established. Potential hazardous situations are identified.
The risks for each hazardous situation have been analysed and evaluated. Risk control
measures are defined and implemented. All known and foreseeable risks, and any
undesirable side-effects, have been minimised and are acceptable when weighed against the
evaluated benefits to the patient and/or user arising from the achieved performance of the
device during normal conditions of use.
For the residual risks that cannot be further eliminated, warning and caution information is
added into the Instructions for Use or put onto the label.
Risk management documentation please refer to Appendix 9.1: Risk Management Plan
and Report.
It is demonstrated that the device in question has been designed and manufactured with the
principle of inherently safe design and construction.
The device is safe and effective and does not compromise the clinical condition or the safety
of patients, or the safety and health of users and/or other persons. It provided that any risks
which may be associated with its use constitute acceptable risks when weighed against the
benefits to the patient and is compatible with a high level of protection of health and safety,
taking into account the generally acknowledged state of the art.
Page 28 of 36
10. Clinical Evaluation
Prior to place the device on the market we have demonstrated through the use of appropriate
conformity assessment procedures that the device complies with the relevant general safety
and performance requirements of MDR, covering safety and performance.
The clinical evaluation provides confirmation of conformity with relevant general safety and
performance requirements set out in MDR Annex I under the normal conditions of the
intended use of the device, and the evaluation of the undesirable side-effects and of the
acceptability of the benefit-risk- ratio referred to in Sections 1 and 8 of Annex I, is based on
clinical data providing sufficient clinical evidence, including where applicable relevant data
as referred to in MDR Annex III.
The clinical evaluation has been performed in accordance with MDR Article 61 and Annex
XIV. As MEDDEV. 2.7.1, Rev. 4:2016 describes details of the method how to perform the
clinical evaluation, it has been also considered in our clinical evaluation.
Disposable masks are considered as well-established devices due to their construction,
clinical use history, material and manufacturing technology, etc. The safety and performance
of the material used and of the device in question are generally recognized by experts circle.
Based on above-mentioned reason, no clinical investigation is needed for such devices.
The clinical performance and clinical safety of the device have been evaluated by assessment
of scientific literature and information from regulator’s database as well as clinical
experience incl. complaints gathered by the manufacturer.
After comparison of the device in question with competitor’s device regarding clinical,
technical and biological characteristics, it was concluded that both devices have similar
design, are used for same intended purpose and under same clinical condition. They use the
same materials in contact with the same human tissues and body fluids. They can be
considered as equivalent devices.
The clinical evaluation demonstrates that any risks which may be associated with the
intended purpose are minimized and acceptable when weighed against the benefits to the
patient and are compatible with a high level of protection of health and safety. The intended
purpose of the device has been confirmed by sufficient clinical evidence, and the label as
well as use information contains correct information to reduce the risk of use error,
information on residual risks and their management as supported by sufficient clinical
evidence.
For each proposed clinical indication:
- the clinical evidence demonstrates conformity with relevant General Safety and
Performance Requirements;
- the performance and safety of the device as claimed have been established; and
- the risks associated with the use of the device are acceptable when weighed against the
benefits to the patient.
Clinical evaluation files are provided in the Appendix 10.1: Clinical Evaluation File.
The clinical evaluation is actively updated:
When we receive new information from Post Market Surveillance that has the potential to
change the current evaluation;
If no such information is received, then at least updated every 2 years.
Post Market Surveillance system will generate new data (e.g. safety reports, results from
published literature; registries, Post Market Clinical Follow-Up studies, and other data about
device usage). These data will be evaluated if it has a potential to change the evaluation of
Page 29 of 36
the risk/benefit profile, the clinical performance and clinical safety of the device, result in
changes to the risk management documents, Instructions for use and Post Market
Surveillance activities.
11. EU Declaration of Conformity
As the device in question meets the General Safety and Performance Requirements set out in
Annex I of MDR which apply to them, a Declaration of Conformity is issued by manufacturer,
refers to Appendix 11.1: Declaration of Conformity.
After completion of the batch-release tests with satisfied results, the production batch will be
released with a batch-related final inspection report. This final inspection report is considered
as a part of declaration of conformity for the produced batch.
The EU declaration of conformity shall contain all of the following information:
1. Name, registered trade name or registered trade mark and, if already issued, SRN as
referred to in Article 31 of the manufacturer, and, if applicable, its authorised representative,
and the address of their registered place of business where they can be contacted and their
location be established;
2. A statement that the EU declaration of conformity is issued under the sole responsibility of
the manufacturer;
3. The Basic UDI-DI as referred to in Part C of MDR Annex VI;
4. Product and trade name, product code, catalogue number or other unambiguous reference
allowing identification and traceability of the device covered by the EU declaration of
conformity, such as a photograph, where appropriate, as well as its intended purpose. Except
for the product or trade name, the information allowing identification and traceability may be
provided by the Basic UDI-DI referred to in point 3;
5. Risk class of the device in accordance with the rules set out in Annex VIII;
6. A statement that the device that is covered by the present declaration is in conformity with
this Regulation and, if applicable, with any other relevant Union legislation that provides for
the issuing of an EU declaration of conformity;
7. References to any CS used and in relation to which conformity is declared;
8. Where applicable, the name and identification number of the notified body, a description of
the conformity assessment procedure performed and identification of the certificate or
certificates issued;
9. Where applicable, additional information;
10. Place and date of issue of the declaration, name and function of the person who signed it
as well as an indication for, and on behalf of whom, that person signed, signature.
Page 30 of 36
Annex III Technical Documentation on Post-Market Surveillance
Page 31 of 36
12. Technical Documentation on Post-Market Surveillance
This part of the technical documentation on post-market surveillance is in accordance with

Articles 83 to 86 of the Regulation (EU) 2017/745. It is to be presented in a clear, organized,
readily searchable and unambiguous manner and includes in particular the elements described
in the MDR Annex III.
The manufacturer is required by the Regulation (EU) 2017/745 to institute and keep up to
date a systematic procedure to review experience gained from devices in the post-production
phase and to implement appropriate means to apply any necessary corrective action and to
notify the competent authorities of relevant incidents. Clinical evaluation is conducted
throughout the life cycle of a medical device, as an ongoing process.
We implement and maintain a Post Market Surveillance system that routinely monitors the
clinical performance and clinical safety of the device as part of quality management system.
The scope and nature of such Post Market Surveillance is appropriate to the device and its
intended purpose.
12.1 Post-market Surveillance Plan and Report
The post-market surveillance system is based on a post-market surveillance plan, the

requirements for which are set out in Section 1.1 of Annex III. The post-market surveillance
plan is part of the technical documentation, refer to Appendix 12.1: Post Market Surveillance
File.
The post-market surveillance plan is drawn up in accordance with Article 84. It addresses the
collection and utilization of available information, in particular:
- information concerning serious incidents, including information from PSURs, and field
safety corrective actions;
- records referring to non-serious incidents and data on any undesirable side-effects;
- information from trend reporting;
- relevant specialist or technical literature, databases and/or registers;
- information, including feedbacks and complaints, provided by users, distributors and
importers; and
- publicly available information about similar medical devices.
The post-market surveillance plan covers following issues:
- a proactive and systematic process to collect any relevant information. The process allows
a correct characterisation of the performance of the devices and also allows a comparison
to be made between the device and similar products available on the market;
- effective and appropriate methods and processes to assess the collected data;
- suitable indicators and threshold values that are used in the continuous reassessment of the
benefit-risk analysis and of the risk management;
- effective and appropriate methods and tools to investigate complaints and analyse market-
related experience collected in the field;
- methods and protocols to manage the events subject to the trend report, including the
methods and protocols to be used to establish any statistically significant increase in the
frequency or severity of incidents as well as the observation period;
- methods and protocols to communicate effectively with competent authorities, notified
bodies, economic operators and users;
Page 32 of 36
- reference to procedures to fulfil the manufacturers obligations laid down in Articles 83, 84
and 86;
- systematic procedures to identify and initiate appropriate measures including corrective
actions;
- effective tools to trace and identify devices for which corrective actions might be necessary;
and
As manufacturer of the medical device we prepare a post-market surveillance report

summarising the results and conclusions of the analyses of the post-market surveillance data
gathered as a result of the post-market surveillance plan together with a rationale and
description of any preventive and corrective actions taken. The report will be updated when
necessary and made available to the competent authority upon request.
12.2 Periodic Safety Update Report (PSUR)
Manufacturers of class IIa, class IIb and class III devices are required to prepare a periodic
safety update report (‘PSUR’) for each device and where relevant for each category or group
of devices summarising the results and conclusions of the analyses of the post-market
surveillance data gathered as a result of the post-market surveillance plan together with a
rationale and description of any preventive and corrective actions taken. Throughout the
lifetime of the device concerned, that PSUR shall set out:
- the conclusions of the benefit-risk determination;
- the main findings of the PMCF; and
- the volume of sales of the device and an estimate evaluation of the size and other
characteristics of the population using the device and, where practicable, the usage
frequency of the device.
Manufacturers of class IIb and class III devices are required to update the PSUR at least
annually. Manufacturers of class IIa devices are required to update the PSUR when necessary
and at least every 2 years.
For class III devices or implantable devices, manufacturers are required to submit PSURs by
means of the electronic system to the notified body involved in the conformity assessment in
accordance with Article 52. The notified body needs to review the report and add its evaluation
to that electronic system with details of any action taken.
As Disposable mask is medical device of class I, no Periodic Safety Update Report is required.
12.3 Post-Market Clinical Follow-Up
Post-Market Clinical Follow-Up (PMCF) is a continuous process that updates the clinical
evaluation and is addressed in the post-market surveillance plan. For conducting PMCF, we
proactively collect and evaluate clinical data from the use in or on humans of a device which
bears the CE marking and is placed on the market or put into service within its intended purpose
as referred to in the relevant conformity assessment procedure, with the aim of confirming the
safety and performance throughout the expected lifetime of the device, of ensuring the
continued acceptability of identified risks and of detecting emerging risks on the basis of factual
evidence. PMCF shall be performed pursuant to a documented method laid down in a PMCF
plan.
The PMCF plan will specify the methods and procedures for proactively collecting and
Page 33 of 36
evaluating clinical data with the aim of: (a) confirming the safety and performance of the device
throughout its expected lifetime, (b) identifying previously unknown side-effects and
monitoring the identified side-effects and contraindications, (c) identifying and analysing
emergent risks on the basis of factual evidence, (d) ensuring the continued acceptability of the
benefit-risk ratio referred to in Sections 1 and 9 of Annex I, and (e) identifying possible
systematic misuse or off-label use of the device, with a view to verifying that the intended
purpose is correct.
The PMCF plan includes at least: (a) the general methods and procedures of the PMCF to be
applied, such as gathering of clinical experience gained, feedback from users, screening of
scientific literature and of other sources of clinical data; (b) the specific methods and procedures
of PMCF to be applied, such as evaluation of suitable registers or PMCF studies; (c) a rationale
for the appropriateness of the methods and procedures referred to in points (a) and (b); (d) a
reference to the relevant parts of the clinical evaluation report referred to in Section 4 and to
the risk management referred to in Section 3 of Annex I; (e) the specific objectives to be
addressed by the PMCF; (f) an evaluation of the clinical data relating to equivalent or similar
devices; (g) reference to any relevant CS, harmonised standards when used by the manufacturer,
and relevant guidance on PMCF; and (h) a detailed and adequately justified time schedule for
PMCF activities (e.g. analysis of PMCF data and reporting) to be undertaken by the
manufacturer. The manufacturer shall analyse the findings of the PMCF and document the
results in a PMCF evaluation report that shall be part of the clinical evaluation report and the
technical documentation. The conclusions of the PMCF evaluation report shall be taken into
account for the clinical evaluation referred to in Article 61 and Part A of the Annex XIV and in
the risk management referred to in Section 3 of Annex I. If, through the PMCF, the need for
preventive and/or corrective measures has been identified, the manufacturer shall implement
them.
As the device in question is a well-established device, the PMCF plan and PMCF evaluation
report referred to in Part B of Annex XIV is not required. The rational for this justification
includes the following aspects:
- the safety and performance of the device are specified and tested acc. to harmonized
standards;
- no side-effects or emergent risks on the basis of factual evidence;
- continued acceptability of the benefit-risk ratio could be made;
- there were no systematic misuse or off-label use of the device.
Page 34 of 36
13 Documentation and Reporting of Design Changes
The technical documentation will include records of each design change and the reasons for
these, together with any associated verification/validation data. The documentation will
include evidence to confirm that the change achieves the desired effect, and that the device
continues to comply with the requirements of the Regulation (EU) 2017/745.
Where the technical documentation or part thereof has been submitted to the Notified Body in
connection with conformity assessment involving design - or type-examination, the
manufacturer is required to inform the Notified Body of substantial changes and obtain
further approval.
The QMR will inform the Notified Body and/or authorized body within 10 days of
“significant” changes to the quality system and/or changes to the device which could affect
compliance with the General Safety and Performance Requirements or the intended use of the
device as described in the SOP – reporting to Regulatory Authority.
A notification of any significant or substantial change may include a change that could
reasonably be expected to affect the safety or effectiveness of the medical devices as follows:
• the key manufacturing process, facility or equipment;
• the key manufacturing, QA/QC control procedures;
• the key design, performance characteristics and specifications of material and device;
• the intended use of the device.
Significant changes that require notification to the Notified Body and/or Competent
Authorities may include but are not limited to the following:
• change that would affect the class of the device
• change in the name of the device
• change in the name or address of the manufacturer
• change in the product design, performance or usage
• change in the manufacturing process or use of critical equipment
• change in the quality testing procedures (materials, process & product)
• change in the name or address of the authorized representative
• change in the identifier of the device, including the identifier of any medical device that
is part of a system, test kit, medical device group, medical device family or medical device
group family.
Other changes requiring reporting may include the change of key personnel such as the QMR
who is responsible for regulatory affairs and the ownership of the Quality Management
System. Upon the approval for changes from the Notified Body within the reasonable time
frame, the QMR will make the necessary amendment and/or changes to the quality system
and/or changes to the device.
Page 35 of 36
Part B
- Appendix 1.3: European Authorized Representative Agreement
- Appendix 2.1: Drawings and Specification
- Appendix 3.1: Product Labelling
- Appendix 4.1: Instructions for Use
- Appendix 5.1: Design and Manufacturing
- Appendix 6.1: General Safety and Performance Requirements Check List
- Appendix 8.1: Type Examination Report
- Appendix 8.2: Biocompatibility Testing Report
- Appendix 8.3: Stability and Transport Validation Report
- Appendix 8.4: Usability Engineering Files
- Appendix 9.1: Risk Management Plan and Report
- Appendix 10.1: Clinical Evaluation File
- Appendix 11.1: EU Declaration of Conformity
- Appendix 12.1: Post Market Surveillance File
Page 36 of 36

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Documentation no.

Regulation (EU) 2017/745

Annex II Technical Documentation

MDR Technical Documentation for

Disposable masks, Type I

Identifier No.: BL/CE-01

Issued Date: 2020-04-01

Version No. Issued date Description of Document Change

A/0 2020-04-01 Initial version

8.2. Product Testing (Performance and Safety) .................................................................. 23

1.1. Legal Manufacturer

1.2. Design and Manufacturing Site

1.3. European Authorized Representative

Address: Mies-van-der-Rohe-Strasse 8, 80807 Munich, Germany

1.4. Conformity Assessment Procedure

1.5. Notified Body

1.6. Declaration that no other Notified Body is used

point of putting into service.

Regulation (EU) 2017/745

Annex II Technical Documentation

2.1. Product Name and Trade Name

Type: Flat ear loop YA-FM

2.2. Product Description

The elastic ear loop has a basic length of 8.0 cm.

- Flat-fold design provides convenient storage prior to use

2.3. Intended Purpose and Indication

As a Disposable mask, it is intended to provide a barrier to minimize the direct transmission

This is a single-use device.

Cautions and Warnings

2.4. Functional Description

Figure 1 Function Mechanism of Disposable masks

Figure 2 Bacterial Filtration Efficiency

2.5. Type, Model, Configurations and Variants

This product is Type I mask acc. to European Standard EN 14683.

2.6. Product Schematic Diagram

Figure 3 Schematic Diagram of Disposable masks

2.7. Product Photo

Figure 4 Disposable masks

Justification of the classification

2.9. Device Subcategory

DEVICE CODE Device subcategory

General non-active non-implantable devices used in health

2.10.Generic Device Group

2.11.Basic UDI-DI or Product Code

2.12.Brochures and Catalogues

2.13. Product Combinations and Accessories

2.14.Similar and Previous Generations of the Device

2.15.Bill of Material and Drawings

Table 1 Bill of Material

Part of Mask Material

Facepiece Non-woven fabric (PP)

Facepiece inlay Melt-blown material (PP)

Ear loop Polyester + Cotton

Nose clip PVC

Packaging material Dispenser box from paper

Outer Packaging Corrugated carton

2.16.Product Performances and Safety Specification