Regulatory Updates
View Profile
New MDCG Guidance: AI Act and MDR/IVDR – What MedTech manufacturers need to know
New MDCG guidance establishes that AI-enabled medical devices require dual compliance with both MDR/IVDR and the AI Act. An overview of how the two frameworks must be integrated in practice.
This month, the MDCG, together with the Joint Artificial Intelligence Board, published a guidance document on how to handle AI-enabled medical devices under the forthcoming AI Act (AIA) in parallel with existing requirements under the MDR/IVDR.
The document introduces the term Medical Device AI systems (MDAIs) and provides a structured overview of how the two regulatory frameworks interrelate. According to the guidance, MDAIs are classified as high-risk AI systems if they serve a medical purpose or are considered a safety component. This means that such products require dual compliance: they must meet all MDR/IVDR obligations and comply with the AI Act’s requirements on aspects such as data governance, transparency, human oversight, cybersecurity, and lifecycle risk management.
Key takeaways include
Single technical documentation: One comprehensive documentation set is expected, integrating both MDR/IVDR and AIA requirements.
Post-market monitoring obligations: Manufacturers must monitor not only clinical performance but also AI-specific behaviours such as unintended interactions or bias.
Conformity assessment: AIA requirements must be embedded in the MDR/IVDR assessment process.
Change management: Substantial modifications to the AI logic may trigger reassessment – unless pre-determined change plans are in place.
Training obligations: Users of MDAIs (e.g. clinicians) must receive adequate training to understand and safely operate the system.
For MedTech manufacturers, this means that the regulatory bar for AI-based products will rise further. It is now essential to integrate AI-specific risk considerations early in product development – and to align quality and documentation processes accordingly. Companies planning to develop or bring to market AI-enabled devices should begin preparing for dual compliance now.
See full document here: AIB 2025-1 MDCG 2025-6
At EUMEDIQ, we are here to support you – whether you need guidance on technical documentation, conformity assessment strategies, or the integration of AI-related requirements into your quality management system. Drop us a mail via info@eumediq.eu.
KEY TAKEAWAY
The MDCG guidance establishes that AI-enabled medical devices, termed Medical Device AI systems (MDAIs), require dual compliance with both MDR/IVDR and the AI Act.
Manufacturers must produce a single integrated technical documentation set, expand post-market monitoring to include AI-specific behaviours such as bias and unintended interactions, and embed AI Act requirements within the MDR/IVDR conformity assessment. Substantial changes to AI logic may trigger reassessment unless pre-determined change plans are in place, and users of MDAIs must receive adequate training to operate the system safely.
RELATED ARTICLES
