Module 14: Design Development and Certification of Medical Devices

22/11/2023

MDR Annex II - Technical Documentation (TD)

BSI whitepaper on technical documentation https://www.bsigroup.com/contentassets/c48f4dd0aa8d4 042987a2fbe72c3e086/white_paper__technical_docume ntation_web_v3.pdf

The Organisation for Professionals in Regulatory Affairs

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Annex II Technical Documentation

Annex III Technical Documentation on Post-Market Surveillance Post-Market Surveillance (PMS) Plan Post-Market Clinical Follow-Up (PMCF) Plan Periodic Safety Update Report (PSUR)

1. Device Description 2. Information to be supplied by the manufacturer 3. Design and Manufacturing Information 4. General Safety and Performance Requirements 5. Benefit-Risk analysis and risk management 6. Product verification and validation

Annex XIV – Clinical Evaluation and Post Market Clinical Follow-Up

The Organisation for Professionals in Regulatory Affairs

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