Transcription of Guidance on legislation
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Guidance on legislation
Guidance on legislation Clinical investigations of medical devices Guidance for manufacturers May 2021 MHRA Guidance on legislation Clinical investigations of medical devices May 2021 2/31 Contents Contents .. 2 Clinical investigation in the UK: .. 4 Is a clinical investigation required: the practical decisions .. 10 Clinical investigations: special circumstances .. 10 Clinical investigations things to consider .. 12 How your application will be handled by the MHRA .. 15 Amendments/modifications .. 19 Final clinical investigation report .. 20 Early termination or temporary halt of clinical investigation .. 20 Adverse events involving devices undergoing clinical investigation .. 20 Study deviations .. 22 MHRA actions / Corrective measures .. 22 UKCA/CE UKNI/CE marking .. 23 Other MHRA Guidance notes .. 23 Glossary of terms.
MHRA. All notifications should be submitted using the application process on the IRAS portal. If, within 60 days of formal acceptance of the Notice, the MHRA has not given written notice of objection, the clinical investigation may proceed. The MHRA may give such notice of objection on
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