Last Updated on 06/11/2025 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))
