MedTech Europe disappointed with EC conclusion on AI Act: UPDATE 25 May 2026

MedTech Europe, the European industry association for the medical technology industry, has published its views on the political agreement reached on amendments to the EU AI Act, commenting that it “is not the outcome MedTech Europe sought.”

The AI Act creates a legal framework to encourage the development of “human-centric and trustworthy” artificial intelligence for products including medical devices and in vitro diagnostics. The Act will take effect on 2 December 2027 for stand-alone high-risk AI systems and 2 August 2028 for high-risk AI systems embedded in products.

The EU co-legislators concluded that medical technologies will remain subject to the AI Act’s high-risk requirements, while industrial AI applications secured an exemption. The organisation had advocated clearly and consistently for a single, sector-specific compliance pathway, whereby high-risk AI requirements for medical technologies would be implemented through the existing Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), rather than through parallel obligations under both frameworks.

Alongside COCIR and DIGITALEUROPE, MedTech Europe engaged directly with Commission President von der Leyen and Member State Permanent Representatives to make the case for regulatory coherence, arguing that the MDR and IVDR already establish rigorous, fit-for-purpose requirements for safety and performance. Layering AI Act obligations on top does not raise the bar; it just adds complexity, increases administrative burden, and risks slowing patient access to innovative technologies.

The European Commission (EC) reaffirmed the horizontal nature of the AI Act, however, while proposing to delay the application of high-risk AI requirements for certain products, including medical devices, until the necessary standards, guidance and compliance infrastructure are in place. MedTech Europe will continue its advocacy efforts, however, to urge the EC to use the MDR/IVDR revision to address the regulatory coherence gap left by this AI Act decision, and ensure that high-risk AI requirements for medical technologies be implemented through the sectoral framework, with no duplication of conformity assessment obligations.

MedTech Europe’s press release on this topic can be accessed here.

UPDATE 25 May 2026: Draft guidelines from the EC aimed to assist companies in determining whether their products are classified as high-risk under the EU’s Artificial Intelligence Act. According to a Commission announcement, “the Guidelines set out the Commission’s interpretation of certain concepts that are relevant for classification purposes and, in accordance with Article 6(5) AI Act, contain practical examples of AI systems that should or should not be classified as high-risk. The examples listed in these Guidelines strive to cover all areas and use cases, but they are not to be considered as exhaustive and may be updated over time.”

The guidelines are divided into three sections, following the structure of Article 6 of I Act, and are accessible from the following links:

1. Draft Guideline #1: On the classification on high-risk AI: General principles
2. Draft Guideline #2: On the classification of high risk AI systems: Annex I of AI Act
3. Draft Guideline #3:  On the classification of high risk AI systems: Annex III of AI Act

The EC has also launched a ‘targeted consultation‘ on the draft guidelines aimed to collect feedback on the clarity of the guidelines and usefulness of the examples. Stakeholders can submit input to this targeted consultation until 23 June 2026.