Yes, for legacy devices, per MDCG 2023-7, a clinical investigation is not required providing there is “sufficient clinical data” – and that can be clinical data from any of the sources listed in Article 2(48), including equivalence (no contract required for legacy devices).

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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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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