MDCG Guidance Documents Clarify Rules on Medical Device Software in the EU

The European Commission’s Medical Device Coordination Group (MDCG) released two guidance documents in June 2025 that define how medical device software (MDSW) is classified, distributed, and regulated across the EU. The updates articulate when software qualifies as a medical device under MDR/IVDR and outline compliance expectations for digital platforms hosting these products, especially under the parallel demands of the Digital Services Act (DSA).  

Qualification and Classification of Medical Device Software – MDCG 2019-11 rev. 1

This updated guidance (originally published in 2019) sharpens the rules for when software qualifies as a medical device or in vitro diagnostic (IVD) device under MDR and IVDR. The key message in this revision is the emphasis on the intended purpose, not where or how the software runs.

Key updates:

• Qualification and classification of software are based exclusively on the intended purpose, irrespective of platform, integration, or delivery method.

• The intended purpose must be clearly and precisely defined; vague or incomplete descriptions may lead to misclassification or regulatory delays.

• To qualify as MDSW, software must have an independent medical purpose. If it solely influences hardware with no standalone function, it is considered an accessory.

• The level of risk does not determine qualification; low-risk software may still be classified as MDSW if its intended use meets the definition of a medical device.

• Rule 11 classification has been clarified: most diagnostic or treatment decision-support tools fall under Class IIa, with Class IIb or III applied to higher-risk use cases.

• Additional guidance has been provided on modular software: medical modules are subject to MDR/IVDR, and non-medical modules must be assessed if they affect the device's overall performance or safety.

Manufacturers should revisit intended purpose statements, classification justifications, and modular designs to ensure alignment with these clarified expectations.

Full guidance here

Safe Distribution of Medical Apps – MDCG 2025-4

This guidance addresses the safe availability of medical device software (MDSW) apps on online platforms within the European Union. It clarifies the obligations and responsibilities of app platform providers under the MDR/IVDR and the Digital Services Act (DSA) and differentiates between app platform providers acting as intermediary service providers and those functioning as distributors or importers of MDSW. Most importantly, it outlines the information manufacturers must provide and the transparency app platforms should ensure to patients.

Key points include:

• clarification of when platform providers may be considered intermediary service providers under the DSA versus distributors or importers under MDR/IVDR (Sections 2.1 and 2.2).

• detailed expectations around trader verification, notice-and-action mechanisms, and platform design to support compliance with EU law (Section 2.1).

• clarification that EU-based platform providers hosting third-country MDSW may take on importer obligations (Section 2.2).

• emphasis on the need for platforms to ensure that all required product information is clearly visible to patients, including device identifiers, intended use, warnings, and access to electronic Instructions for Use (Section 2.3).

• recommendation that platforms create distinct product categories to help patients differentiate certified MDSW from general health or wellness apps (Section 2.3).

App platform providers should review their role on a case-by-case basis, confirm whether MDR/IVDR or DSA obligations apply, and update internal processes accordingly. Platforms qualifying as Very Large Online Platforms (VLOPs) under the DSA should also ensure risk assessments and due diligence checks are in place.

Full guidance here

Key Action Items for EU MDSW Compliance

Medical device manufacturers of MDSW should ensure their intended purpose statements and classification rationales to ensure alignment with MDCG 2019-11 rev. 1, especially for modular or decision-support tools. For those distributing through digital platforms, it’s essential to assess whether importer or distributor obligations apply under MDR/IVDR and the DSA. Clear, accessible product information (i.e., device identifiers, intended use, and electronic IFUs) must be made available to users. Finally, manufacturers should evaluate internal processes to ensure compliance with EU expectations for software hosted, developed, or supported across borders.

Learn more about EU MDR and IVDR consulting.

‍