Public consultation launched: EU Commission seeks feedback on reform of MDR and IVDR
30 January 2026
The European Commission has taken an important step in the ongoing legislative process by initiating a public consultation on the planned reform of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations. The starting point is the proposal, published on 16 December 2025, to amend the Medical Devices Regulation (MDR, EU 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR, EU 2017/746), as well as other accompanying legal acts.
Comment period
As part of the open consultation, companies, associations, and other stakeholders are invited to submit comments by 4 March 2026. This feedback will inform further discussions at the European level and help design future regulatory requirements.
Reform goals
The reform proposal aims to make the existing medical device regulations more practical, efficient, and manageable. At the same time, the Commission is pursuing the goal of strengthening innovation and competitiveness while maintaining a high level of patient safety.
Key focus
A key focus of the reform proposal is reducing administrative burdens by simplifying and coordinating procedures. Certification processes will become more predictable and efficient through shorter timeframes, adapted classification rules, and greater use of real-world data.
Plans also include more proportionate requirements for products with low- and medium-risk profiles and for small patient groups; the expansion of digital processes, such as electronic instructions for use and digital conformity assessments; targeted promotion of innovation; and stronger EU-wide coordination, including the involvement of expert committees and the European Medicines Agency (EMA).
Relevance
The ongoing public consultation gives all stakeholders the opportunity to contribute their experiences with the MDR and IVDR and help shape the reform process.
If you have any questions about the proposed changes or their potential impact on current and future products, feel free to get in touch with our experts.
