Technical Documentation
Build compliant technical documentation per Annexes II and III — from device description through clinical evaluation and SSCP.
- 1
Technical Documentation Overview
What Annexes II and III require and how the documentation set fits together.
12 minRequires: Overview of Conformity Assessment - 2
Device Description and Specification
Documenting intended purpose, design, materials, and manufacturing processes.
14 minRequires: Technical Documentation Overview - 3
General Safety and Performance Requirements
Walking through Annex I GSPRs and demonstrating compliance for each applicable requirement.
16 minRequires: Technical Documentation Overview - 4
Benefit-Risk Analysis
Risk management per ISO 14971, benefit-risk determination, and residual risk acceptability.
14 minRequires: General Safety and Performance Requirements - 5
Clinical Evaluation
Clinical evaluation reports, literature reviews, clinical investigations, and equivalence claims.
18 minRequires: Benefit-Risk Analysis - 6
Labelling and Instructions for Use
MDR labelling requirements, UDI, symbols, implant cards, and instructions for use per Annex I Chapter III.
12 minRequires: Technical Documentation Overview - 7
Summary of Safety and Clinical Performance
SSCP requirements under Article 32, document structure per MDCG 2019-9, and the link to implant cards.
14 minRequires: Clinical Evaluation