Medical Devices Regulation (MDR) 2017/745 - Annex IX Assessment of Technical Documentation https://www.aretezoe.com/medical-devices

1. Assessmentof
Technical
Documentation
ANNEX IX, CHAPTER II
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 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

3. PAGE 3
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

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 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

5. PAGE 5
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

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 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

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 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

8. Assessment by NB: III, IIb
 Manufacturer needs to apply to NB for assessment of technical documentation
 Technical documentation Annexes II and III
 NB may conduct own tests or request more tests from the manufacturer
 NB shall review the clinical evidence, may use external experts
 NB shall assess the suitability of claimed equivalence and document its conclusion
 NB verifies adequacy of clinical evaluation
 NB verifies manufacturer’s conclusions on conformity
 NB documents outcome of its assessment
 Report on the Technical documentation assessment
 Changes to approved device need to be approved by NB
PAGE 8

9. PAGE 9
Assessment by NB: III implantable, IIb active administering medicines
NB verifies quality of clinical data
supporting clinical evaluation report
NB transfers the clinical evaluation report
and its assessment to European
Commission
EC transmits the documents to relevant
expert panel
NB may be asked to present its conclusions
to the expert panel

10. PAGE 10

11. PAGE 11
Expert panel
Expert panel provides scientific opinion
If the device has major clinical impact
due to novelty
In case of a significant worsening of risk
profile
Or in case of significant increase in
serious incidents

12. PAGE 12
Expert panel assessment
 Reasoned decision advising NB to proceed with certification
 Expert panel notifies the EC through Eudamed
No opinion within 60 days: NB can proceed with certification
NB considers scientific opinion in its decision.

13. PAGE 13
Expert panel scientific opinion
 Expert panel is supervised by the Commission
 Expert panel may provide scientific opinion if:
 The device has major clinical impact due to novelty
 Significant worsening of risk profile
 Significant increase in serious incidents
 reasoned decision advising NB to proceed (or not) with certification

14. PAGE 14
Devices incorporating a medicinal substance
Medicinal substance subject to Annex I of Directive 2001/83/EC
NB needs to seek scientific opinion from relevant medicinal
products authority (national or EMA)
Competent authority has 60 days to provide opinion
NB needs to consider this opinion in its decisions

15. PAGE 15
 subject to Directive 2004/23/EC
 NB submits preliminary assessment
 Relevant authority provides opinion within 120 days
 NB considers opinion and issues final decision
 Supplement to the EU technical documentation assessment certificate
Devices incorporating a human tissues and cells
Cells and tissues of human origin

16. PAGE 16
Devices incorporating animal tissues and cells
Cells and tissues of animal origin
 subject to Regulation (EU) 722/2012
 NB shall apply relevant requirements
to their assessment directly

17.  subject to Directive 2001/83/EC
 NB shall seek scientific opinion from relevant
national competent authority or EMA
 Scientific opinion within 150 days
 NB must consider the opinion in its assessment
PAGE 17
Devices that are composed of
substances or their combinations that
are absorbed by or locally dispersed in
the human body

18.  Subject to Directive 2001/83/EC
 Batch verification
 Manufacturer releases a batch and
notifies NB
PAGE 18
Devices incorporating a
medicinal product derived from
human blood or plasma