In December 2025, the European Commission published a proposal for a targeted revision of the Medical Device Regulation (MDR, Regulation (EU) 2017/745) and the In Vitro Diagnostic Regulation (IVDR, Regulation (EU) 2017/746). The initiative builds on experience gained since the MDR became applicable in May 2021 and aims to address implementation challenges, including certification bottlenecks, administrative burden and risks to device availability, while maintaining the high level of patient safety established under the current framework.

The proposal seeks to improve the predictability and efficiency of conformity assessment procedures, notably through more structured interaction with notified bodies and a shift towards continuous, risk-based surveillance. It introduces more proportionate requirements for certain “well-established technologies”, streamlines selected post-market and reporting obligations, and removes the fixed maximum validity of CE certificates in favour of ongoing oversight.

The reform also strengthens provisions on digitalisation and cybersecurity, including enhanced reporting of serious cybersecurity incidents and greater use of electronic documentation and EUDAMED (European Database on Medical Devices). In addition, it seeks to clarify the interaction between the MDR/IVDR and other EU legislations, including rules applicable to software and AI-enabled medical devices.

The proposal was developed following a targeted evaluation of the existing MDR and IVDR frameworks, aimed at identifying key shortcomings and challenges in the current legal framework (see ESR response here). This was complemented by a Call for Evidence launched by the European Commission in late 2025, which sought stakeholder input on how to address the identified issues in a targeted and proportionate manner (see ESR response here).

Following the publication of the legislative proposal, the European Commission launched a public consultation on the targeted MDR/IVDR revision, providing stakeholders with the opportunity to share their views on the proposed amendments ahead of the next stages of the legislative process.

Given radiology’s extensive reliance on regulated imaging equipment, medical software, and increasingly AI-enabled technologies across the entire clinical pathway, the proposed reform is of particular relevance to the ESR’s work. This importance is reflected in the ESR’s response to the public consultation, which calls for a balanced, risk-based, and innovation-friendly regulatory framework for AI-enabled medical devices, while highlighting the need for strengthened post-market surveillance, improved generation and use of real-world evidence, and greater regulatory predictability.

The European Parliament is also actively contributing to the discussion. In June 2026, the Committee on Public Health (SANT) published its draft report on the Commission’s proposal. While the revision has broad political support, a number of amendments have been proposed. After the vote on the amendments, the European Parliament is expected to adopt its final report in autumn 2026, setting out its position ahead of discussions with the Council.

In parallel, the Council of the European Union is progressing its examination of the file. The Irish Presidency has identified the MDR/IVDR revision as a priority and aims to advance negotiations with the objective of reaching a Council position by the end of its Presidency in December 2026.

The ESR is closely monitoring developments in both the European Parliament and the Council and is assessing the potential implications of the reform for radiological practice, innovation, access to medical technologies, device availability, and patient safety.

For more information, please visit the following links:

• EC Proposal for MDR/IVDR Revision
• European Commission Staff Working Document Evaluation of MDR/IVDR Revision
• MDR Factsheet
• EUDAMED – European Database on Medical Devices
• ESR response to the Call for Evidence on MDR (2025)
• ESR response to the Call for Evidence on the EC Proposal for a revision (2025)
• ESR response to the MDR Revision Consultation (2026)
• European Parliament draft report on the proposal for MDR/IVDR revision