UK MHRA Updates & Adds New Resources on Post-Market Surveillance (PMS) and Vigilance
11 June 2025
Targeted Evaluation of the MDR & IVDR: Summary Report on Open Consultation Responses
23 June 2025Background
This document is one of the items on the MDCG list of ongoing/planned guidance scheduled for Q2 2025.
Its purpose is to clarify the role of app platforms, and if/when the app platform provider is considered an economic operator under the MDR/IVDR. This helps close an information gap, since the role of app providers was not included in MDCG 2021-27, the Q&A on MDR/IVDR Article 13 (importers) and Article 12 (distributors).
The guidance does not alter the definition of medical device software or the software manufacturer’s obligations under the MDR or IVDR.
Note: for more information on the differences between importers and distributors, please read: EU Guide on Importers under the MDR/IVDR
Overview of MDCG 2025-4
The MDCG published a new guidance document on the legal status of app platform providers: HERE
MDCG 2025-4 includes non-MDR/IVDR definitions from the Digital Services Act (DSA), such as an “intermediary service” and an “online platform”.
Placing on the Market & Making Available on the Market
The guidance clarifies how ‘placing on the market’ and ‘making available on the market’ are defined for software apps.
| Action | Definition |
|---|---|
| The upload of a medical device software (MDSW) app by a manufacturer | “placing on the market” |
| The time during which the MDSW app is available via the app platform provider | “making available on the market” |
App Platform Providers as Economic Operators
The determination of whether an app platform provider is considered an economic operator under the MDR/IVDR depends on their activities and involvement in the supply chain.
| Action | Status | Examples |
|---|---|---|
| App platform provider acts as an intermediary service provider, including as an online marketplace, i.e., an online platform allowing consumers to conclude distance contracts with traders, where the product is made available to the user by the manufacturer, importer or distributor. | The app platform provider is not considered an importer or distributor (and therefore not an economic operator) under the MDR/IVDR. Instead, the overarching Digital Services Act (DSA) principles as liability exemption (Article 6) and non-general monitoring obligations (Article 8), fully apply. | Examples: The Apple App Store, Google Play Store, Huawei AppGallery, and Amazon Appstore. The key is that the app platform provider does not take ownership of the app and instead only facilitates the download between the two parties. |
| Where the manufacturer makes a MDSW app available to an app platform provider in a commercial or non-commercial activity, and the app platform provider in turn makes that product directly available to the user as a distributor or importer by, for example, transferring the ownership or other rights. | The app platform provider is considered an importer or distributor (as applicable) under the MDR/IVDR and must comply with the obligations outlined under Article 13 (importers) or 14 (distributors). An app platform provider would be considered an importer if the app manufacturer resides in a third country outside of the European single market. | Example 1: An MDSW app is pre-installed on a device sold by a third-party. E.g., the app was provided to a digital health company, and they pre-install it onto a tablet and distribute the tablet + software combo to clinics or patients. Example 2: A hospital hosts a 3rd party app and makes it available externally, e.g., regional telemedicine practitioners, referring physicians, or affiliate clinics. Note the criteria to make it available “externally”. If a hospital obtains an MDSW app directly from the manufacturer and deploys it only within its internal IT systems, for use by its own staff, the hospital is considered a professional end user under the Blue Guide. And it is therefore not subject to importer or distributor obligations. However, if that hospital makes the app available to professionals outside its own organization (e.g., affiliated clinicians, external networks), then it may assume the role of an importer or distributor. |
Other topics covered within MDCG 2025-4
These include:
- Recommendation that app platform providers clearly differentiate between a medical device software app and health apps with no medical purpose. For example, separate libraries in which a MDSW app manufacturer can select the appropriate category when making their products available on the platform.
- Advisement that, in accordance with Article 31 (1) and Article 31 (2) of the DSA, app platform providers shall ensure that their online interface allows traders, including medical device manufacturers, to provide the minimum information required, e.g., name, address, telephone number, and email address of the economic operator as defined in Article 3, point (13), of Regulation (EU) 2019/1020 and other Union law, and information concerning the labeling and marking in compliance with the rules of applicable Union law on product safety and product compliance
- After allowing traders to offer their products on the online platform, the platform provider shall make reasonable efforts to randomly check any official, freely accessible, and machine-readable online database or online interface, whether the products or services offered have been identified as illegal.
- Very Large Online Platforms must comply with Article 34 and 35 of the DSA, which requires them to conduct risk assessments and mitigate those identified risks.
