[Amie]

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).

[Amie]

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).