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Holly replied to the discussion Definition of "clinical investigation" in the forum Clinical Evidence 3 months ago

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…

Amie started the discussion Definition of "clinical investigation" in the forum Clinical Evidence 3 months ago

3 months ago

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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