MDR revision: a major opportunity to restore proportionality and efficiency of the system for all
On 16 December 2025, the European Commission proposed a targeted revision of the Regulation (EU) 2017/745 on medical devices (MDR) with the objective of addressing key challenges identified during the implementation of the current framework. This proposal responds to repeated calls from the European Parliament, Member States, and stakeholders to simplify the regulatory framework and improve the availability of medical devices within the Union. As recognised in the evaluation accompanying the proposal, the increased administrative burden resulting from the Regulation could be addressed by streamlining reporting obligations as well as avoiding duplication and overlapping of reports and their assessment. The proposal aims to improve the proportionality, efficiency, and predictability of the system in order to ensure continued patient access to safe and innovative medical devices across the Union, while ensuring a very high level of patient safety.
EuromContact generally welcomes the European Commission’s proposal and supports its swift adoption, while we recommend a number of targeted and technical clarifications and limited additional improvements to address remaining shortcomings in the MDR framework, in order to fully achieve the intended objectives of regulatory efficiency, consistency, proportionality while strengthening the EU’s attractiveness for innovative technologies.