Amie
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Amie updated their profile a week ago
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Amie and
Daria are now connected 7 weeks ago -
Amie and
Dongeun are now connected 7 weeks ago -
Amie joined the group
7 weeks agoRisk Management 7 weeks ago -
Amie joined the group
7 weeks agoRegulatory 7 weeks ago -
Reply to Definition of "clinical investigation"
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).
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Elizabeth and
Amie are now connected 8 weeks ago -
Jude and
Amie are now connected 8 weeks ago -
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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