Last Updated on 23/08/2023 by Sarah Sarsby
MHRA – Guidance on Class I Medical Devices: Although derivative of the full guidance in Sections 7-8 above, this advice on Class I medical devices – eligible for self-certification in most cases because of their low risk profile – is a useful guide; e.g. MHRA lists areas that must be covered by a manufacturer’s Technical File; in summary these are:
Product Description
Raw Material and Component Documentation
Intermediate Product and Sub-Assembly Documentation
Final Product Documentation
Packaging and Labelling Documentation
Packaging Specifications / Copies of All Labels / Any Instructions for Use
Design Verification
Risk Analysis
Compliance Requirements (per UK MDR 2002, Part II, Annex I (as modified by UK MDR 2002, Schedule 2A, Part II))
Clinical Evaluation (per UK MDR 2002, Part II, Annex X (as modified by UK MDR 2002, Schedule 2A, Part II))
Declaration of Conformity (per UK MDR 2002, Part II, Annex VII (as modified by UK MDR 2002, Schedule 2A, Part II))