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.

Under the EU’s Medical Device Regulation (MDR), the rules around sterilization impact almost every aspect of product design, manufacturing, packaging, and documentation. For medical device manufacturers placing sterile products on the EU market, sterility isn’t just another technical specification – it’s an added weight on their regulatory burden. Here’s what you need to know about sterility standards and MDR compliance.