Amie
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Reply to Definition of "clinical investigation"
However, it also means that, if your device is Class III or implantable, a retrospective study will not satisfy the requirement for a clinical investigation per Article 61(4). In practice this should only affect a small number of manufacturers (ie, those that launched a device outside the EU and then say a few years later decide they’d like to…
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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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This product was advertised to me on X/Twitter: http://www.humehealth.com – the health claims on X were pretty explicit (eg “early warning of health problems”). They seemed to have toned it down somewhat on their website, but I think some of these claims still put them into medical device territory in the EU… but I cannot see anything resembling a…
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