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.

Software as a Medical Device (SaMD) vendors have faced years of uncertainty around compliance for making products available on app stores. The big question: Are these digital marketplaces classed as ‘distributors’ under the EU Medical Device Regulation (MDR)? It was unclear, until now.

With the release of MDCG 2025-4, the Medical Device Coordination Group has clarified a longstanding gray area around the role of digital marketplaces in the SaMD market. In a recent conversation with regulatory expert Marijn Maas from Peercode Regulatory Consultancy, we unpacked what this new guidance means for those people in your organization leading compliance efforts for SaMD.

Patient safety is paramount for medical device companies. It’s the cornerstone of both the design and regulatory approval process under the EU Medical Device Regulation (MDR). One of the most critical and complex areas where safety must be proven is biocompatibility. Whether you’re developing skin-contacting sensors or implantable devices, demonstrating that your product is safe for the human body is critical for gaining and maintaining market approval in Europe.