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))
Sarah joined BHTA in April 2018.
After graduating with a Masters in English Language from De Montfort University, Sarah works across all BHTA publications (including AT Today and THIIS).