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