MDCG guidance

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Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during June and early July 2025 from the United Kingdom and European Union.

There has been a flurry of new guidance from the Medical Device Coordination Group this month, including guidance on classification of medical device software, on supply of software apps through online platform such as the App Store and Google Play, and on the interaction between the Medical Device Regulation and the EU AI Act. These are welcome guidance documents to provide important clarification for manufacturers as they develop software medical devices, although the guidance documents inevitably cannot cover every situation and leave some questions unanswered. Continue Reading Virtual and Digital Health Digest – July 2025

The recently published MDCG 2025-4 guidance provides important clarifications on how Medical Device Software (MDSW) apps should be made available via online platforms and on the role of these online platforms. With digital distribution channels such as the App Store and Google Play playing a central role in healthcare software deployment, the guidance has significant implications for medical device manufacturers operating in the EU.

In essence, the guidance clarifies that digital distribution does not reduce regulatory obligations. Software-based medical devices must be subject to the same level of regulatory scrutiny and compliance as traditional, physical devices.

We set out below some comments on the distinction between platforms acting as intermediary service providers under the Digital Services Act (DSA) and those that may qualify as importers or distributors under the EU Medical Devices Regulations (the MDR and IVDR).Continue Reading EU Medical Device Software: New guidance on placing software medical devices on the EU market

Earlier this month, the European Commission published a “rolling plan” for the implementation of the new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). As we mentioned in our blog from last year, CAMD’s (Competent Authorities for Medical Devices) Implementation Taskforce published a high-level MDR/IVDR roadmap setting out how the Regulations will be implemented, and the order in which key guidance and clarification will be developed. Now, the Commission has published the rolling plan, which contains a list of the essential implementing acts and actions that need to be introduced, as well as providing information on expected timelines and the current state-of-play.
Continue Reading Update on the European MDR and IVDR