Updates in Medical Device Law – Update as of May 11, 2026

At the international level, the regulatory landscape for medical devices is constantly evolving. For all stakeholders, this means staying informed about new developments and adapting internal processes in a timely manner.

On May 7, 2026, the European Commission, the Council, and the European Parliament agreed on a reform of the AI Regulation. In its press release, the European Commission specifically announced a new timeline for the transition periods: Regulations for systems used in certain high-risk sectors (e.g., critical infrastructure and education) are to take effect as of December 2, 2027. Regulations for systems integrated into products (e.g., medical devices), however, are not set to take effect until August 2, 2028. The agreement confirms the implementation timeline already proposed by the European Commission last year. The EU has thus now clarified its common goal—however, the formal and legally binding implementation of the aforementioned transition periods is still pending.

We have already summarized further developments at the EU level in our article dated December 3, 2025.