Medical Devices Regulation (MDR) 2017/745 - Annex IX Conformity Assessment: Quality Management Systems & Technical Documentation https://www.aretezoe.com/medical-devices

1. ANNEXIX
CONFORMITYASSESSMENT
QMS &TECHNICAL
DOCUMENTATION
MEDICAL DEVICES REGULATION 2017/745
ANNEX IX, Chapter I and III
PAGE 1

2. PAGE 2
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

3. PAGE 3
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

4. PAGE 4
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

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 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

6. PAGE 6
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

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 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

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 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

9. PAGE 9
Annex I
General safety and
performance
requirements
Annex XIII
Documentation
Annex XI Part A
Production Quality
Assurance
Custom-made class III implantable devices
Annex XI
Quality Management
System
Chapter I
Annex IV
Declaration of
Conformity
Annex V
CE Marking

10. PAGE 10
QMS Assessment
 Manufacturer applies for assessment to NB
 Devices covered
 Draft EU declaration of conformity
 Documentation of Quality Management System
 Description of procedures in place
 Documentation of post-market surveillance system
 PMCF plan
 Clinical evaluation plan

11. PAGE 11
QMS Implementation
 Ensure compliance with MDR 2017/745
 Documented in systematic and orderly manner
 Manufacturer’s quality objectives
 Organizational structure
 Methods of monitoring of QMS effectiveness
 Final verification of testing
 Designation of authorized representative

12. PAGE 12
QMS Implementation
 Procedures and techniques QMS of design
 Documentation, data, records
 Strategy for regulatory compliance
 Identification of relevant legal requirements
 Qualification, classification, handling of equivalence
 Conformity assessment procedures
 Risk management
 Clinical evaluation and Post-market clinical follow-up
 Solutions for fulfilling applicable specific requirements
 Change management

13. PAGE 13
QMS Audit
 NB shall audit manufacturer’s QMS
 Audit team shall include at least one member with experience
with the specific technology
 IIa and IIb: assessment of QMS + assessment of technical
documentation
 Consider MDCG guidance
 NB issues EU QMS certificate
 Manufacturer informs NB of any significant changes

14. PAGE 14
Surveillance assessment
 Devices class IIa, IIb, III
 Manufacturer gives authorization to NB to carry out on site audits
 Manufacturer provides relevant documentation
 NB shall carry out audit and assessment at least once a year
 Random unannounced audits every 5 years
 NB shall test adequate sample of devices
 Class IIa and IIb – assessment of technical documentation
 Class III – test of the approved parts
 NB can suspend or withdraw relevant certificates or impose restrictions

15. PAGE 15
Administrative provisions
 Manufacturer shall keep documentation for 10 years, implantable devices 15 years
 EU Declaration of Conformity
 Data on Quality Management System
 Information on changes of Quality Management System
 Decisions and reports from NBs
 Member States shall require the documentation remains available in case of bankruptcy