They have done it!! EU Commission's new proposal for MDR

As promised and in time, the latest proposal to amend Regulations (EU) 2017/745 and 2017/746 aims to recalibrate how evidence is generated and used for medical devices, with a particular focus on non-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. We will have to read the text carefully and find the way from interpretation.

For many devices that are not classified as high risk, safety and performance may be demonstrated adequately on the basis of non-clinical data, including new approach methodologies (NAMs). In this context, the proposal seeks to give greater prominence to the possibility of relying on such non-clinical evidence within the conformity assessment under Regulation (EU) 2017/745.

Clinical data are frequently available for devices that are equivalent to the product undergoing conformity assessment. To make it easier for manufacturers to rely on equivalence, the current requirement in Regulation (EU) 2017/745 for a contractual agreement with the manufacturer of the equivalent device, granting access to its technical documentation, is to be removed and the equivalence criteria adjusted accordingly.

Post-market clinical follow-up (PMCF) remains a key obligation under Regulation (EU) 2017/745, as it is essential for detecting safety issues that may arise during real-world use. In order to reduce the reporting burden, the proposal allows manufacturers to integrate PMCF findings directly into the updated clinical evaluation, rather than preparing additional, separate reports. It remains unchanged that post-marketing surveillance may only be waived in justified cases.