On 16 December 2025, the European Commission published a proposal to amend the EU regulatory framework for medical devices and in-vitro diagnostic medical devices.

The objective is to simplify existing rules, reduce administrative burden, improve predictability, and support innovation and competitiveness, while maintaining a high level of patient safety and public health protection.

In our latest 5-minute guide, our Founder Jörg Dogwiler summarises the key elements in the proposal, indicative timings for implementation, and practical implications for medical device and IVD manufacturers. Take a look below for the summary, and to read the full proposal from the EU Commission, see here.

Our Regulatory team is ready to help with your MDR & IVDR strategy – get in touch to start the conversation.