Apps that are considered medical devices are subject to strict regulations in the EU – and app platforms are also responsible. Our FAQ explains the most important aspects of the MDCG Guidance Document 2025-04 of the EU Medical Device Coordination Group.
What is an MDSW app and why is its security important?
A medical device software app (MDSW app) is software that is used for medical purposes – for example to diagnose or control therapies. It can be used directly by patients. Its safety is crucial as it can have a direct impact on health. MDSW apps must therefore comply with strict EU requirements (in particular MDR (EU 2017/745) and IVDR (EU 2017/746)).
What role do app platform providers play in MDSW apps?
App platforms can simply provide MDSW (e.g. as hosting services) or actively distribute them. In the first case, they are considered intermediaries and are primarily subject to the Digital Services Act (DSA, EU 2022/2065). However, if they assume ownership or distribution of the app, they are considered distributors or importers and must comply with the requirements of the MDR/IVDR.
What legal requirements apply to MDSW apps in the EU?
Mainly the MDR (EU 2017/745) and IVDR (EU 2017/746) apply. In addition, the DSA (EU 2022/2065) applies to platform providers. All legal requirements must be met before an MDSW app can be offered in the EU.
What obligations do platforms have as intermediaries?
As intermediaries under the DSA, platforms must, among other things:
- offer mechanisms for reporting illegal content,
- Enable transparency of product information,
- very large platforms (VLOPs) must carry out additional risk analyses.
When are platform providers considered distributors or importers?
If they actively distribute MDSW apps or assume ownership rights, they are considered economic operators and must comply with all MDR/IVDR requirements – e.g. on product safety and cooperation with authorities.
What information must manufacturers provide?
MDSW manufacturers must provide clear information according to MDR/IVDR, e.g:
- Contact and manufacturer information,
- Product details (name, UDI, purpose),
- Safety and operating instructions.
Why is app categorization important?
So that users can distinguish between genuine medical device apps and general health apps. Only apps with MDR/IVDR conformity may be labeled as “medical devices”.
What additional inspection obligations do platforms have?
Platform providers must also comply with the DAS:
- Check dealer information before activating,
- Randomly check products for legality,
- analyze and mitigate systemic risks annually for very large platforms.
What to do now?
- Identify MDSW: Check whether your app is classified as a medical device.
- Ensure legal compliance: Ensure that all required product information, labeling and evidence is available.
- Clarify roles: Check whether your platform is acting as an intermediary, distributor or importer – and fulfill the corresponding obligations.
- Create transparency: Design your platform so that users can clearly recognize relevant information about MDSW apps.
- Establish risk assessment and monitoring: Large platforms in particular should introduce and document processes for risk assessment and mitigation.
Now is the right time to close regulatory gaps – before supervisory authorities become active. We are happy to provide support.
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