The European Commission's (EC) recent proposal to revise the regulatory framework for medical devices marks a pivotal moment for the industry, particularly regarding the application of the EU AI Act to medical devices.

Following the effective date of the EU AI Act (2 August 2026 for Annex III, and 2 August 2027 for Article 6 (1)), AI-powered medical devices could be subject to both the EU AI Act and the MDR or the IVDR. Requiring dual compliance would pose significant challenges for manufacturers, resulting in regulatory complexity and delayed market access.

However, the EC's proposal "COM(2025) 1023 final," published in December 2025, intends to introduce a disruptive shift: AI-based medical devices will be classified as "Annex B products," effectively exempting them from the majority of the regulation's requirements (cf., Article 2 (2) EU AI Act), and regulatory oversight would be streamlined under the MDR/IVDR, with the EC tasked with updating Annex I of both regulations, taking into account the EU AI Act. This includes adapting requirements to scientific and technological advances, addressing emerging risks, and aligning MDR and IVDR with new international standards. Common Specifications (CS) will also play a key role in ensuring harmonized standards across the EU. While this is already the case under Article 9 MDR and Article 9 IVDR, the CS are expected to play an important role in regulating AI-based medical devices.

The proposal, which also includes other simplifications for medical devices, is currently under review by the European Parliament and the Council. Industry participants are encouraged to engage in consultations and provide feedback during this phase to help shape practical requirements.

For medtech companies, the EU AI Act exemption for medical devices promises a more predictable and innovation-friendly environment. The removal of overlapping obligations may accelerate the development and deployment of AI-driven medical devices, while maintaining robust safety and performance standards through the MDR/IVDR framework. However, given the Commission's mandate to align this framework with the EU AI Act, it can be expected that significant parts of the EU AI Act's material requirements will be incorporated into the MDR/IVDR through updates to Annex I and CS.

It will be crucial for stakeholders to stay informed, especially regarding upcoming updates to Annex I, and the potential introduction of new CS. With the Commission tasked with updating the MDR/IVDR and the impending effective dates of the EU AI Act, requirements may evolve quickly.

All things considered, the proposed exemption represents a major simplification for AI-powered medical devices in the EU. Stakeholders can make their voices heard in the legislative process and push for practical requirements, and should closely monitor further developments while preparing for a dynamic yet streamlined compliance landscape.