Under the EU Medical Device Regulation (MDR), manufacturers are required to demonstrate that their products are clinically safe and effective. This requires robust clinical data, particularly for higher-risk devices. Clinical investigations sit at the intersection of scientific discovery and regulatory compliance. 

We spoke with one of Dawn Technology’s regulatory consultants, Erwin Waas, about the complexities of clinical investigations, how clinical data requirements are managed, and the vital role he and his colleagues play in guiding medtech companies and scientists through the compliance process.

AI is reshaping the compliance burden for medical device companies in the EU. Thankfully, for makers of medical devices containing AI, the Medical Device Coordination Group (MDCG) has released a crucial piece of guidance material.

MDCG 2025-6 outlines the interplay between the EU’s Medical Device Regulation (MDR), In Vitro Diagnostic Medical Device Regulation (IVDR), and the Artificial Intelligence Act (AI Act). It comes just in time: the full application of the AI Act to high-risk systems, including medical devices, is set to take effect one year from now.  

We sat down with Dawn Technology (formerly Peercode) regulatory consultant Marijn Maas to unpack the implications of this landmark guidance and what vendors of medical device software can do to prepare.

Under the EU’s Medical Device Regulation (MDR), the classification of software has long been a gray area. While Rule 11 specifically addresses Software as a Medical Device (SaMD), its interpretation has often varied between manufacturers and Notified Bodies. The original MDCG 2019-11 guidance helped, but ambiguities remained, especially for modular or integrated software systems.

The recently updated MDCG 2019-11 sets out how manufacturers of SaMD should approach classification, especially in modular or complex software systems. We spoke with Marijn Maas, a regulatory consultant at Peercode, to understand what’s new, what’s clarified, and what’s still open to interpretation.