In its press release, published on 1 August 2025, marking one year since the entry into force of the Artificial Intelligence (AI) Act, MedTech Europe calls for a coherent and complementary implementation of the legislation to fully unlock AI’s potential in healthcare.
Lack of alignment between AI Act and medical sector regulations
MedTech acknowledges the EU’s ambition to create a forward-looking regulatory framework. Nonetheless, it warns that the lack of alignment between the AI Act and existing sectoral legislation. Parallel application of MDR and IVDR with the AI Act risks creating overlapping legal requirements, regulatory uncertainty, and delays in patient access to innovative technologies.
MedTech proposals for a better AI-medical regulatory framework interplay
To avoid unintended barriers to innovation and ensure legal clarity, MedTech Europe urges the European Commission to exempt clinical investigations and performance studies conducted under MDR and IVDR from AI Act obligations. It also calls for the extension of the AI Act’s application date for medical technologies from 2 August 2025 to 2 August 2029. This will allow time for drafting necessary guidance, and establishing harmonised standards, and enforcement structures.
The organisation, furthermore, advocates for allowing existing MDR and IVDR Notified Bodies to carry out AI conformity assessments. It, moreover, proposes the introduction of AI-specific technology codes to streamline implementation. MedTech Europe emphasises that a coherent, predictable, and well-aligned framework is essential for Europe to lead in the safe and innovative use of AI in healthcare.
Do you need assistance understanding your current MDR or IVDR obligations? Contact us.
References
MedTech Europe (2025). One year of AI Act: MedTech Europe calls for coherent implementation to unlock the full potential of AI in healthcare. Retrieved on 6 August 2025.
Leave a Reply