Medical Devices Regulation (MDR) 2017/745 - Conformity assessment https://www.aretezoe.com/medical-devices

1. CONFORMITY
ASSESSMENT
MEDICAL DEVICES REGULATION 2017/745
CHAPTER V, SECTION II, ANNEXES IX, X, XI
PAGE 1

2. PAGE 2
CONFORMITY ASSESSMENT
PROCEDURES
• Required prior to placing a device on a
market or putting it into service
• Class III – Annex IX
• Class IIb – Annex IX, chapters I and III
• Class IIb – type examination, Annex X
• Class IIa - Annex IX, chapters I and III
• Class IIa – Annexes II and III + Section
10 or 18 of Annex XI
• Class I – Annexes
ANNEX V - CE MARKING OF CONFORMITY

3. PAGE 3https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=country.notifiedbody&cou_id=276
As of 27 Dec 2019

4. PAGE 4https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=country.notifiedbody&cou_id=276
Austria, Belgium, Bulgaria, Czech Republic, Croatia, Cyprus, Denmark, Estonia, Finland, France,
Greece, Hungary, Iceland, Ireland, Latvia, Lichtenstein, Lithuania, Luxembourg, Malta, Norway,
Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Turkey
As of 27 Dec 2019

5. Involvement of Notified Bodies
 Not required for devices Class I (non-sterile, non-reusable, w/o measuring function)
 Not required for custom-made devices (excl. custom-made class III implantable)
 Manufacturer may apply to a NB of its choice (one only)
 NBs inform each other about withdrawn applications in EUDAMED
 Manufacturer has the duty to disclose withdrawals and refusals
 NB has the right to request any information required for conformity assessment
 NBs are subject to CHAPTER IV and ANNEX VII
 Voluntary change of NB shall specify details in an agreement
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6. PAGE 6
Annex I
General safety and
performance
requirements
Annex II
Technical
Documentation
Annex III
Technical
Documentation on
Post-market
surveillance
Annex IV
Declaration of
Conformity
Class I (other) Annex V
CE Marking
Class I – sterile, reusable,
measuring function
Annex IX
Quality Management
System, Chapters I, III
Annex XI Part A
Production Quality
Assurance
Class I Devices
Manufacturer only
Annex IV
Declaration of
Conformity
Annex V
CE Marking

7. PAGE 7
Annex I
General safety and
performance
requirements
Annex II
Technical
Documentation
Annex III
Technical
Documentation on
Post-market
surveillance
Annex IX
Quality Management
System,
Chapters I, III
Annex IX
Chapter II
Technical documentation
per device category
Annex XI Part A
Production Quality
Assurance
Annex XI Part B
Production
verification
Class IIa Devices
Annex IV
Declaration of
Conformity
Annex V
CE Marking

8. PAGE 8
Annex I
General safety and
performance
requirements
Annex IX
Quality Management
System
Chapters I, III
Annex IX
Chapter II
Technical documentation
per device generic device
group
Annex X
Type Examination
Annex XI Part B
Production verification
Class IIb Devices Annex VIII Rule 12
All active devices intended to administer and/or remove medicinal
products, body liquids or other substances to or from the body are classified
as class IIa, unless this is done in a manner that is potentially hazardous,
taking account of the nature of the substances involved, of the part of the
body concerned and of the mode of application in which case they are
classified as class IIb.
Annex IX Sec.5 / Annex X Sec. 6
Clinical Evaluation Consultation Procedure
Annex XI Part A
Production Quality
Assurance Annex IV
Declaration of
Conformity
Annex V
CE Marking

9. PAGE 9
Annex I
General safety and
performance
requirements
Annex IX
Quality Management
System
Chapters I, III
Annex IX
Chapter II
Technical documentation
per device generic device
group
Annex X
Type Examination
Annex XI Part B
Production verification
Class IIb Implantable Well-Established Technologies
Class IIb non-implantable (non-rule 12, non-WET)
Annex XI Part A
Production Quality
Assurance
Well-established technologies (WET): sutures, staples, dental fillings, dental braces,
tooth crowns, screws, wedges, plates, wires, pins, clips and connectors
Annex IV
Declaration of
Conformity
Annex V
CE Marking

10. PAGE 10
Annex I
General safety and
performance
requirements
Annex IX
Quality Management
System
Chapters I, III
Annex IX
Chapter II
Technical documentation
For every device
Annex X
Type Examination
Annex XI Part B
Production verification
Class IIb Implantable devices (non-WET)
Annex XI Part A
Production Quality
Assurance
Well-established technologies (WET): sutures, staples,
dental fillings, dental braces, tooth crowns, screws,
wedges, plates, wires, pins, clips and connectors
Annex IV
Declaration of
Conformity
Annex V
CE Marking

11. PAGE 11
Annex I
General safety and
performance
requirements
Annex IX
Quality Management
System
Chapters I, III
Annex IX
Chapter II
Technical documentation
For every device
Annex X
Type Examination
Annex XI Part B
Production verification
Class III non-implantable devices
Consultation
2001/83/EC
EC/726/2004
2004/23/EC
EU/722/2012
Annex XI Part A
Production Quality
Assurance
Annex IV
Declaration of
Conformity
Annex V
CE Marking

12. PAGE 12
Annex I
General safety and
performance
requirements
Annex IX
Quality Management
System
Chapters I, III
Annex IX
Chapter II
Technical documentation
For every device
Annex X
Type Examination
Annex XI Part B
Production verification
Class III Implantable devices
Consultation
2001/83/EC
EC/726/2004
2004/23/EC
EU/722/2012
Annex XI Part A
Production Quality
Assurance
Annex IX Sec.5 / Annex X Sec. 6
Clinical Evaluation Consultation Procedure
Annex IV
Declaration of
Conformity
Annex V
CE Marking

13. PAGE 13
Annex I
General safety and
performance
requirements
Annex XIII
Documentation
Annex XI Part A
Production Quality
Assurance
Custom-made class III implantable devices
Annex IX
Quality Management
System
Chapter I
Annex IV
Declaration of
Conformity
Annex V
CE Marking

14. PAGE 14
Annex I
General safety and
performance
requirements
Statement
Annex III Section 1
Annex XIII
Documentation
Custom-made devices (excl. Class III implantable)
Annex XIV Part B
PMS, PMCF

15. Clinical Evaluation Consultation Procedure
Class III implantable devices
Class IIb devices (Rule 12) designed to administer/remove medicinal product
 Section 5.1 of Annex IX, as referred to in Section 6 of Annex X
 Not required in devices with only minor modifications or
where the principles were already addressed in Common
Specifications.
 European Commission prepares annual overview of devices
subject to this procedure.
 NB notifies competent authorities of issued certificates and
enters them in EUDAMED
 Include Summary of Safety and Clinical Performance
 Subject to scrutiny at national and EU level
PAGE 15

16. Certificates of conformity
 Issued in accordance with Annex IX, X and XI
 Official language as specified Member State
 Valid for specified period, max. 5 years
 NBs may impose restrictions to intended
purpose, groups of patients or PMCF studies
 NBs may suspend or withdraw certificates;
such decisions have to be justified
 NBs enter information on certificates in
EUDAMED
 Competent authorities may authorize placing
a device on the market in case of public
health need
PAGE 16

17. Authority, Address
Certificate of Free
Sale
Log
o
Certificate number
Devices: Annex reference
Basic-UDI
Manufacturer’s details
Confirmation that the device
mentioned above can be legally
marketed in EU countries and meets
the requirements of the MDR
2017/745Date, Place, Signature
PAGE 17

18. EUDAMED
The new EUDAMED database will include:
 Registration of devices
 Unique Device Identifiers
 Registration of economic operators (except for
distributors)
 Notified bodies, Certificates
 Clinical investigations
 Vigilance, Post-market surveillance
 Market surveillance (inspections, non-
compliance, health protection measures)
PAGE 18
Article 29, 30, 31
Part A of Annex VI
https://ec.europa.eu/docsroom/documents/33862/attachments/1/translations/en/renditions/native
 Functional specifications defined by EC and
Medical Device Coordination Group (MDCG)
 Information accessible to general public
 information on UDIs facilitates traceability
 Information on clinical investigations
 Reporting serious incidents
 Field Safety Corrective Actions
 EUDAMED will serve EU/EEA authorities to
cooperate and exchange information

19. PAGE 19

20. Annexes
 Annex I – General safety and performance requirements
 Annex II – Technical documentation
 Annex III – Technical documentation on post-market surveillance
 Annex IV – EU Declaration of Conformity
 Annex V – CE marking of conformity
 Annex XII – Certificates issued by a notified body
CONFORMITY ASSESSMENT PROCEDURES
 ANNEX IX – Quality Management System and assessment of Technical Documentation
 ANNEX X - Type examination
 ANNEX XI – Product conformity verification
 ANNEX XIII – Procedure for custom-made devices
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21. PAGE 21
Manufacturer’s details
Name, trade mark, SRN, authorized
address
Device
Product, trade name, product code (catalogue
number, photograph), intended purpose, basic
DI, risk class
Common Specifications
Notified Body
Name, identification #
Date, Place, Signature
The EU declaration of conformity is issued under the
sole
responsibility of the manufacturer.
The device that is covered by the present declaration
is in conformity with EU Medical Devices Regulation
2017/745 (& any other Union legislation)
EU declaration of
conformity
Annex IV: EU Declaration of Conformity
Annex V: CE marking of conformity

22. PAGE 22
Certificates issued by NB
Manufacturer (Authorized representative)
Name, address, SRN
Device
Product, trade name, product code, intended
purpose, risk class
Basic UDI-DI
Common Specifications, harmonized standards
Examinations, tests performed, test reports and
reports
Conclusions, Conditions, Limitations, additional
documents required
Notified Body Name, Address, Identification #
Unique number identifying the certificate
Date of issue: Date of expiry:
Previous certificates issued
EU Medical Devices Regulation 2017/745 and
relevant Annex
Certificate of
conformity
 EU Technical documentation assessment certificate
 EU type-examination certificate
 EU product verification certificate
 EU quality management system certificate
 EU quality assurance certificate (Class I)