Clinical Evidence
Group dedicated to all things clinical evidence
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Definition of “clinical investigation”
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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 the definition in the EU MDR (“any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device”) – to my mind a retrospective study could still satisfy those criteria.
However, the logic is (some of you may already know this), the word “involve” in the MDR is assumed to mean actively involve – as in recruit, inform, consent, etc, from the beginning. To my mind that’s a subtle nuance of language – and apparently the ambiguity varies quite significantly depending on which language you read the MDR in (I’m told, for example, that it’s even more ambiguous in French, but completely unambiguous in Romanian).
Feel free to chime in with your thoughts 🙂
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4 Replies
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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 the primary concern becomes data privacy and ensuring GDPR compliance.
Retrospective clinical studies is an incredibly robust tool to obtain real world evidence and satisfy some of the clinical evidence requirements!
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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 do a study using retrospective data collected in that country – nah-ah. not a clinical investigation, so that data is not sufficient)). However, the exemptions for legacy and WET devices remain, and so retrospective studies could be used in those cases to satisfy clinical evidence requirements (because “investigations” are not mandatory in those cases).
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It’s interesting that you say that because I actually have successfully helped manufacturers of Class IIB and III implantable legacy devices satisfy the requirements for clinical data with retrospectively collected data via PMCF. BUT they were also legacy devices so it would not necessarily support a new product being brought to market under MDR – those will still be bound to the clinical investigation requirements. But there are many Class IIB implantable and III devices on the market that can successfully leverage retrospective data (of course depending on the targeted population, treated conditions, specific and measurable outcomes, etc).
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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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