Juni 25, 2025
Regulatory
Guidance to Promote Safer Apps
In everyday life and healthcare settings, both patients and medical professionals are increasingly turning to mobile applications. Recently, a new guidance document was published to address the safe distribution of medical device software (MDSW) apps on online platforms.
Although there have been previous publications offering guidance on MDSW, this latest document specifically outlines the duties and responsibilities of platform providers. It aligns with the European Medical Devices Regulation (MDR) 2017/745, the In-vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746, and the Digital Services Act (DSA). The guidance aims to clarify what platform providers must do to support MDSW manufacturers in making their applications available within the European market.
Which Regulations Take Priority?
When multiple regulations apply to the same entities operating within the EU market, certain rules take precedence. Specifically, the Medical Devices Regulation (MDR), In-vitro Diagnostic Medical Devices Regulation (IVDR), and the Digital Services Act (DSA) all set out obligations for companies providing products or services. The MDR and IVDR define roles such as importers, distributors, European Authorized Representatives, and manufacturers as key economic operators. Meanwhile, the DSA targets online platforms, service providers, and intermediary entities. This means that platform providers can be classified as importers or distributors under the scope of the MDR, IVDR, and DSA.
In cases where both sets of laws are applicable, the liability exemption outlined in Article 6 of the DSA takes precedence, and the platform must adhere to the non-general monitoring obligations specified in Article 8. Platforms that enable users to enter into contracts with MDSW manufacturers are subject to DSA requirements, including having procedures to detect and respond to illegal content. Regulatory authorities may also require these platforms to remove illegal material related to medical device software.
Furthermore, transparency and compliance standards outlined in Article 31 of the DSA must be followed, which are similar to the obligations under MDR and IVDR regarding user instructions and safety warnings.
An especially noteworthy point is that large online platforms, or those designated by the European Commission, are required to implement risk assessment procedures and can be held responsible for illegal content they host or facilitate.
What You Need to Know as a Platform Provider
The classification of a platform provider—either as a distributor or an importer—depends on the location of the Medical Device Software (MDSW) manufacturer. If the manufacturer is based within the European Union, the platform provider is considered a distributor. Conversely, if the manufacturer is situated outside the EU, the platform provider acts as an importer. Additionally, manufacturers outside the EU are required to appoint an EU Authorized Representative to ensure compliance. According to Articles 13 and 14 of the MDR/IVDR regulations, both importers and distributors are obligated to collaborate with Competent Authorities. This means that major online platforms, such as app stores operated by Apple and Google, will need to work closely with regulatory bodies and the European Commission moving forward.
View document on the European Commission's website: MDCG 2025-4 - Guidance on the safe making available of medical device software (MDSW) apps on online platforms (June 2025) [external link]