MDCG 2019-11: Qualification and classification of software
The MDCG has revised its guidance on the qualification of software as a medical device (MDCG 2019-11). The key changes at a glance:
- The new version stresses the great importance of a clear intended purpose as the basis for qualifying and classifying software (modules).
- The guidance contains numerous new examples of software that counts as a medical device, and of software that explicitly does not.
- The modular approach is highlighted, with more attention paid to the fact that software products are often made up of both medical device modules and non-medical device modules.
- A new example of a class I app is given, although it is not a typical DiGA case (a patient training app) but a rather specific product.
The new guidance therefore brings somewhat more clarity and lets manufacturers of class I products breathe a little easier. Nothing has changed about the general approach to classification and the corresponding decision tree. Nevertheless, the product examples given for classification are not helpful for every product, which means there will continue to be considerable room for interpretation for some products in practice.
You can find the updated MDCG guidance here: Update MDCG 2019-11 rev.1 – Qualification and classification of software – Regulation (EU) 2017/745 and Regulation (EU) 2017/746 (June 2025)
MDCG 2025-6: Interplay between the MDR and the AI Act
The MDCG has also published a FAQ document with answers on the interplay between the MDR/IVDR and the AI Act: MDCG 2025-6. The document contains explanations on various topics arising from the AI Act for medical devices and their manufacturers. Specifically, the following topic areas are covered:
- Scope of the AI Act and classification of products
- Requirements for products and manufacturers
- Clinical and performance evaluation and testing
- Conformity assessment
- Substantial modifications
- Post-market monitoring
For manufacturers who want to develop a medical device containing artificial intelligence, the document is definitely worth a look. If you are interested in the effects of the AI Act on medical devices, we also recommend a look at our expert article on the topic: AI Act: A Guide for Medical Device Manufacturers under the MDR (2025)
You can find the MDCG guidance here: MDCG 2025-6 – FAQ on Interplay between the Medical Devices Regulation & In vitro Diagnostic Medical Devices Regulation and the Artificial Intelligence Act (June 2025) – European Commission
MDCG 2025-4: Safe making available of medical device software on app platforms
MDCG 2025-4 carries the somewhat unwieldy title “Guidance on the safe making available of medical device software (MDSW) apps on online platforms”.
The document is aimed at providers of large app platforms (such as the Google Play Store and the Apple App Store). It describes in more detail the extent to which such platforms must ensure that manufacturers of medical device apps are able to meet their obligations under the MDR.
The guidance is therefore rather positive for app manufacturers, as it places greater obligations on app platform providers to help with implementing regulatory requirements. How large providers such as Google and Apple will respond, however, remains to be seen.
This guidance too can be found, as usual, on the website of the EU Commission: MDCG 2025-4 – Guidance on the safe making available of medical device software (MDSW) apps on online platforms (June 2025)