Fine-Tuning the MDR? What the New Article 74 Proposal Means for PMCF Investigation

The latest proposal to amend Regulations (EU) 2017/745 and 2017/746 aims to recalibrate how evidence under Art. 74  is generated for medical devices, with a particular focus on clinical data and post-market activities.

Such a proposal from the European Commission marks the formal start of an EU legislative amendment process, signalling a clear political and regulatory intention to adjust and clarify how the MDR and IVDR are to be applied in practice.

A recent clarification of the MDR rules for PMCF investigations shows how precisely the Regulation is being fine-tuned. For regulatory and clinical teams, it is worth taking a closer look at the detailed changes.    

Clearer link to the PMCF plan    

In the revised wording, PMCF investigations must now be conducted “in accordance with its PMCF plan”. This makes it more explicit that additional invasive or burdensome procedures cannot be planned in isolation but must be consistently embedded within the PMCF plan.    

More precise documentation requirements    

Instead of referring broadly to “Chapter II of Annex XV”, the new text narrows the required documentation down to “Chapter II, Sections 1, 3 and 4, of Annex XV”. This sharpens the focus of the submission: not the entire chapter, but clearly defined parts are required for the notification of PMCF investigations.    

More accurate allocation of legal provisions    

The references to applicable articles are now more granular: Article 62(4), points (b) to (k) and (m), Article 75(1), Articles 76 and 77, and Article 80(5) and (6). At the same time, it is clearly stated that these requirements apply specifically to PMCF investigations involving additional invasive or burdensome procedures. This improves legal certainty for sponsors planning such studies.    

In practice, this means that while the legal text appears more precise on paper, it still leaves manufacturers navigating an unresolved tension between the MDR’s wording and evolving guidance, with the actual level of evidence expected by notified bodies remaining opaque.    

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MEDIACC is also involved in the group that is authorised to propose further optimisations and close the remaining regulatory gap for clinical investigations of medical devices.

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