Medical Devices Regulation (MDR) 2017/745 - Annex II Technical documentation https://www.aretezoe.com/medical-devices

1. ANNEXII
TECHNICAL
DOCUMENTATION
MEDICAL DEVICES REGULATION 2017/745
ANNEX II
ANNEX IX
PAGE 1

2. ANNEX II
TECHNICAL DOCUMENTATION
PAGE 2
• Applies to devices Class I and IIa
• Device description and specification
• Labeling
• Information on design
• Demonstration of conformity with Annex I
• Benefit-risk analysis
• Pre-clinical and clinical data
• Additional information

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. Device description
 Product name, general description, intended
purpose
 Basic UDI-DI
 Patient population
 Rationale for classification as device
 Risk class
 Accessories
 Complete list of configurations/variants
 Key functional elements
 Raw materials incorporated
 Technical specifications
 Previous and similar generations
PAGE 5

6. PAGE 6
Design and manufacturing
information
 Information on design stages
 Complete information and specifications
 Manufacturing processes
 Validation, continuous monitoring
 Final product testing
 Complete data
 Identification of all sites, including suppliers and sub-contractors, where design
and manufacturing activities are performed.

7. PAGE 7
Information supplied by manufacturer
 A complete set of labels
 Language(s) as required by Member State(s)
 Information on design

8. General Safety and Performance Requirements
Demonstration of Conformity with Annex I
 Intended purpose, justification, validation, verification
 General safety and performance requirements that apply
 Explanation as to why other requirements do not apply
 Methods used
 Harmonized standards, Common Specifications
 Precise identity of the controlled documents
 Evidence of conformity with standard
 Cross-references
 Summary technical documentation.
 Risk-benefit analysis, risk management (Sections 1, 3, 8 of Annex I)
PAGE 8

9. PAGE 9
Pre-clinical and clinical data
 Engineering, laboratory, simulated use, animal tests (Good Laboratory Practice )
 Published literature regarding the pre-clinical safety (similar devices)
 Test design, study protocols
 Methods of data analysis, data summaries and test conclusions
 Biocompatibility, physical, chemical and microbiological characterization
 Electrical safety and electromagnetic compatibility
 Software verification and validation
 Stability, including shelf life
 Performance and safety

10. Pre-clinical and clinical data
PAGE 10
Clinical evaluation
report and its
updates
Clinical evaluation
plan (Part A of
Annex XIV)
PMCF plan and
PMCF evaluation
report (Part B of
Annex XIV)

11. Additional information
 Medicinal product
 Human or animal cells and tissues
 Substances introduced into/onto human body
 Carcinogenic, Mutagenic, Reproduction toxicity (CMR) and endocrine
disruptors above limit
 Sterilization and maintenance of sterility
 Accuracy of measuring functions
 Combinations and configurations
PAGE 11

12. Post-Market
Surveillance
Medical Device Regulation 2017/745
Chapter VII, Section 1, Article 83 to 86
ANNEX III
PAGE 12

13. PAGE 13
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

14. PAGE 14
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