Medical Devices Regulation (MDR) 2017/745 - Annex XI, Conformity assessment, Product conformity verification see more https://www.aretezoe.com/medical-devices

1. ANNEXXI
CONFORMITYASSESSMENT
PRODUCTCONFORMITY
VERIFICATION
MEDICAL DEVICES REGULATION 2017/745
ANNEX XI – PART A, PART B
PAGE 1

2. Product conformity verification
 The objective of the conformity assessment based on
product conformity verification is to ensure that devices
conform to the type for which an EU type-examination
certificate has been issued, and that they meet the
provisions of this Regulation which apply to them.
 Devices with EU type-examination certificate:
 Part A (production quality assurance)
 or Part B (product verification)
 By way of derogation of the above, this procedure may
also be applied to class IIa devices.
PAGE 2

3. PAGE 3
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

4. PAGE 4
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

5. PAGE 5
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

6. PAGE 6
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

7. PAGE 7
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

8. PAGE 8
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

9. PAGE 9
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

10. PAGE 10
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

11. PART A - PRODUCTION
QUALITY ASSURANCE
PAGE 11
ANNEXXI
CONFORMITYASSESSMENT
PRODUCTCONFORMITY
VERIFICATION

12. Quality Management System
 Manufacturer shall have a QMS that is subject to surveillance
 Manufacturer applies to NB for assessment
 Technical documentation, EU-type examination certificates
 QMS shall ensure compliance with EU type-examination certificates and MDR 2017/745
 All elements, requirements and provisions shall be documented
 NB issues EU Quality Assurance Certificate
PAGE 12

13. Surveillance
 Annex IX applies as relevant
 Class III – check that quantities of raw
materials and crucial components
correspond with the quantities of
finished devices
 Batch verification in case of devices
incorporating product derived from
human blood or plasma.
 Manufacturer informs NB of batch
release and supplies certificate issued by
designated laboratory
PAGE 13

14. Administrative
 Documentation has to be kept 10 years after the last device
had been placed on the market (implantable 15 years
 EU Declaration of Conformity
 Documentation of Quality Management System
 EU type-examination certificate
 Information on changes
 Decisions and reports issued by NB
PAGE 14

15. Class IIa devices
 NB shall assess whether the technical
documentation is compliant with this Regulation
 Representative sampling for conformity assessment
 For sampling, NB shall consider novelty, technology,
similarities in design, manufacturing and
sterilization methods, intended use, previous
assessments
 Additional sampling as part of surveillance
PAGE 15
Documents archived for 10 years:
 EU declaration of conformity
 Technical documentation (Annexes II, III)
 Certificate (Section 10.3)
 Batch release

16. ANNEXXI
CONFORMITYASSESSMENT
PRODUCTCONFORMITY
VERIFICATION
PART B – PRODUCT
VERIFICATION
PAGE 16

17. Product verification
 Examination of every manufactured device
 Conformity in accordance with Article 19 and Annex IV
 EU type-examination certificate
 Documents defining the manufacturing process, in particular sterilization
 Manufacturing process designed to secure and maintain sterility
 Post-market surveillance plan, including a PMCF plan
 Vigilance and post-market surveillance system
 NB shall carry out examinations and tests to verify conformity
PAGE 17

18. Verification by examination and testing every product
 Every device shall be examined individually
 NB shall carry out appropriate physical or laboratory
tests to verify conformity of the devices
 NB shall affix its identification number to each
approved device
 Batch verification (products incorporating medicinal
substance, human blood or plasma):
 Manufacturer shall inform NB of batch release and
send it official certificate concerning the blood/plasma
component issued by a national laboratory
PAGE 18
EU type-
examination
certificate
EU product
verification
certificate
List of tests
and
assessments
carried out
Issued by NB Issued by NB

19. Class IIa devices
 EU Declaration of conformity (Annex II, III)
 NB verifies conformity with Annex II and III
PAGE 19
Documents archived for 10 years:
 EU declaration of conformity
 Technical documentation (Annexes II, III)
 Certificate (Section 10.3)