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Reply to Definition of "clinical investigation"
Hi Amie – this is absolutely spot on, and allows for effective use of retrospective studies for the purpose of PMCF that do not require EU oversight or prior ethics committee approval (there are of course limitations to this, but thats generally the case in most scenarios). The study does not impact clinical management of the patient, so…
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Definition of "clinical investigation"
I learned something recently: in the EU, retrospective studies are not considered “clinical investigations”. I realise that MDCG 2021-6 spells this out, but I thought they meant, “they aren’t investigations that you need to apply to a competent authority for”. But, no, they mean, at all. I can see why intuitively, but if you strictly go by…
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Felicia updated their profile a year ago
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Updates to the MHRA Clinical investigations for medical devices were published today, including a flowchart and additional guidance for when submitting clinical investigations conducted in the UK are required. Follow the links below:
- Updated webpage: …
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Reply to Event Announcement for this amazing forum!
Signed up – cant wait for this one!
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