The Medical Devices Introductory Course 2020

Technical Documentation Annexes II & III - New

• In MDD was called the “technical file” or “design dossier” • Contains the necessary technical and administrative information to demonstrate the conformity of your product • Required for all devices • “… shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements listed in this Annex”

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

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Technical Documentation Contents, Annex II

• Description of device and variants • Intended Use and Device Classification • Drawings and specifications • Materials and biocompatibility • Design and manufacturing documentation (including sterilisation if applicable) • General Safety and Performance Requirements Checklist • Risk Management File • Pre-clinical Test Reports (Performance, EMC, Safety, etc.) • Clinical Evaluation Report • Labels and Instructions for Use • Ancillary Medicinal Product Dossier for drug-device combination products • Declaration of Conformity • Unique Device Identifier (UDI)

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

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