Annex II — Technical Documentation

Source: EU MDR 2017/745 Annex II | OJ L 117, 5.5.2017

Technical Documentation Structure

1. Device Description and Specification

Device name, generic name, model/type
Intended purpose (including patient population, indications, contraindications)
Device classification and classification rationale (Annex VIII classification rules)
UDI (Unique Device Identifier)
Description of the device and its accessories, components

2. Manufacturer and Authorised Representative Information

Manufacturer name and registered address
Authorised Representative (if applicable)
All manufacturing sites

3. Design and Manufacturing Information

Design phase information (design drawings, components, circuit diagrams, etc.)
Description of manufacturing processes
List of materials used

4. General Safety and Performance Requirements (GSPR)

List of applicable GSPRs
Method used to demonstrate conformity with each GSPR
Harmonised or other standards applied
Evidence of conformity

5. Benefit-Risk Analysis and Risk Management

Risk management file (conforming to EN ISO 14971)
Benefit-risk analysis conclusion

6. Product Verification and Validation

Design verification and validation results
Biocompatibility evaluation (EN ISO 10993 series)
Sterilisation validation (if applicable, EN ISO 11135/11137/17665 series)
Software validation (if applicable, EN IEC 62304)
Electrical safety and EMC testing (if applicable, EN IEC 60601 series)
Stability and shelf-life testing

7. Clinical Evaluation

Clinical Evaluation Report (CER) (conforming to Annex XIV)
Post-Market Clinical Follow-up (PMCF) plan

Technical Documentation Retention Requirements

Technical documentation shall be retained for at least 15 years (implantable devices) or 10 years (other devices) after the last device has been placed on the market
Shall be available for inspection by competent authorities at any time

Official Sources