On December 16, 2025, the European Commission published a legislative proposal substantially revising the Regulations 2017/745 (MDR) and 2017/746 (IVDR).
The proposal, if adopted, would simplify the regulatory framework, reduce administrative burdens, improve the predictability and cost-effectiveness of certification, while maintaining a high level of patient safety.
To become law, the proposal must now be adopted by both the European Parliament and the Council of the EU, which is announced for Q2 2027. Given the widespread concerns about device shortages and the regulatory burden, the legislative process may be prioritized even further.
One might say this is a very welcome holiday gift from the European Commission, and certainly one that fits better under the tree than another guidance document.
MDSS will present the key elements of the proposal, share our regulatory input, and discuss the potential impact on manufacturers and other economic operators during our upcoming online seminar in January.
👉 Register now to stay ahead of the regulatory changes and understand what this proposal could mean for your business.
