Clinical investigations of medical devices – compiling a ...
Guidance on legislation Clinical investigations of medical devices . compiling a submission to MHRA. MHRA Guidance on legislation Contents 2. Submitting a Clinical investigation for MHRA assessment ........................................ ........................ 4. Prior to notifying the MHRA of a Clinical investigation ........................................ ............................... 5. IRAS Form and supporting documentation required ........................................ ................................. 7. MHRA devices submission checklist on IRAS ........................................ .................................. 7. Documentation required for all applications ........................................ ....................................... 7. 1. Covering letter on headed paper.
(MDR) and the In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR) will apply in Northern Ireland from 26 May 2021, and 26 May 2022 respectively, in line with the EU’s implementation timeline. This means that clinical investigations being conducted in Northern Ireland must meet the
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