EU MDR and IVDR targeted revision consultation now open

The European Commission is collecting feedback on the proposed targeted MDR and IVDR revision. Stakeholders can submit their views from 7 January until 6 March 2026.

Ongoing revision of the EU medical devices regulations

Since 2024, the European Commission has been conducting a targeted evaluation of the medical devices and IVDs regulations (MDR and IVDR). In response to calls from the European Parliament, Member States, and stakeholders, a targeted revision is planned to simplify and future-proof the framework. The initiative seeks to simplify and streamline the EU medical device regulatory framework while maintaining high standards of patient safety and public health. Its goals include reducing administrative and reporting burdens, improving the predictability and cost-efficiency of certification by notified bodies, making conformity assessments more proportionate, especially for low-, medium-risk and special-needs devices, and expanding digitalisation. It also aims to streamline governance procedures, strengthen international cooperation where appropriate, and better align the framework with other relevant EU legislation.

How to submit your feedback

Stakeholders have an opportunity to express their views and share evidence by accessing the consultation here.

The main stakeholder groups identified include:

• the competent authorities in EU Member States and EEA states;
• independent third-party bodies that assess the conformity of medical devices (‘notified bodies’);
• economic operators, and the associations representing them, active in the field of medical devices;
• healthcare professionals, and the associations representing them;
• patients and consumers, and the associations representing them;
• civil society organisations;
• independent experts from academic and research institutes;
• experts on regulatory affairs, and the associations and companies;
• the general public;
• European bodies, including the European Medicines Agency;
• international intergovernmental organisations and international associations;
• non-EU/EEA countries.

Contact our MDlaw Team here or at mdlaw@obelis.net for any questions on the medical devices regulations.