MDCG 2025-5 clarifies essential aspects of IVD performance studies, including study types, sponsor responsibilities, and safety reporting. The revised MDCG 2019-11 offers updated guidance on software qualification and classification, with expanded definitions, examples, and a revised decision tree. MDCG 2025-4 outlines the obligations for manufacturers and distributors when making medical device software available via online platforms. Finally, MDCG 2025-6 provides clarity on how the MDR and IVDR interact with the EU Artificial Intelligence Act (AIA), highlighting parallel compliance requirements for AI-powered medical devices.
MDCG 2025-6: Interplay Between the MDR/IVDR and the Artificial Intelligence Act (AIA)
Published: 19 June 2025
This new guidance outlines how the regulatory frameworks for medical devices (MDR), in vitro diagnostic medical devices (IVDR), and the Artificial Intelligence Act (AIA) interact, particularly when medical device software includes AI systems.
Main highlights:
- Clarifies that AI systems embedded in or as medical devices must comply with both MDR/IVDR and AIA requirements.
- Emphasizes the role of notified bodies in the conformity assessment under MDR/IVDR and how this relates to AIA obligations, especially for high-risk AI systems.
- Recommends coordination between authorities responsible for medical devices and those overseeing AI compliance.
- Encourages manufacturers to integrate AIA risk management, data governance, and transparency requirements into their MDR/IVDR quality system and technical documentation.
Key takeaway:
Manufacturers of medical devices and IVDs incorporating AI should proactively ensure that their systems meet the requirements of both legal frameworks, as parallel compliance will be expected for products placed on the EU market.
MDCG 2025-5: Questions & Answers on Performance Studies for IVDs
Published: 18 June 2025
This new Q&A document addresses practical questions surrounding the planning and conduct of performance studies for in vitro diagnostic devices under the IVDR. Topics include:
- The distinction between different types of studies (e.g. clinical vs. analytical performance)
- Responsibilities of the study sponsor, including academic institutions
- When to notify or apply for authorization under Articles 58 and 70
- How to manage modifications to studies after submission
- Clarifications on specific scenarios, such as the use of leftover samples or performance studies involving companion diagnostics
Key takeaway: The document provides concrete guidance to help manufacturers and sponsors correctly interpret the regulatory requirements when conducting IVD performance studies in the EU, including when and how to engage with competent authorities and ethics committees.
MDCG 2019-11 Rev.1: Qualification and Classification of Software
Revised: 17 June 2025
This is the first revision of the earlier 2019 guidance document on how to determine whether software qualifies as a medical device and how it should be classified under the MDR or IVDR.
What’s new in this revision:
- Enhanced decision logic and clearer examples to determine whether software qualifies as a medical device
- Refined explanations on how to apply the classification rules, especially Rule 11 under MDR
- Additional guidance on handling software composed of multiple modules, including those that are not considered medical devices
- Clarifications on the inclusion of software without a medical purpose (under Annex XVI of the MDR)
- References to interoperability considerations in the context of broader EU digital health initiatives
Key takeaway: This updated guidance helps software developers and manufacturers understand how to justify the intended purpose of their software, navigate classification rules, and address situations where software functions extend beyond strictly medical uses.
MDCG 2025-4: Guidance on Making Available MDSW and Apps via Online Platforms
Published: 16 June 2025
This document provides practical advice for manufacturers and distributors of medical device software (MDSW), as well as online platforms like app stores that make such software available to users in the EU.
Main highlights:
- Clarifies how the roles of manufacturer, distributor, and importer apply to online platforms, depending on how the software is uploaded and accessed
- Explains what it means to “place on the market” vs. “make available” MDSW
- Emphasizes the need for clear separation between medical and non-medical (e.g. wellness) apps
- Sets expectations for transparency, including how CE marking and labeling information should be communicated via platforms
- Addresses obligations under the Digital Services Act (DSA), including traceability, user protections, and mechanisms to flag non-compliant software
Key takeaway: Manufacturers and platform providers need to ensure that MDSW offered via online channels is accompanied by the required regulatory information and that responsibilities are clearly defined within the supply chain.
What does this mean to you?
If you are:
- Conducting IVD performance studies: ensure your study plans and submission strategies align with the Q&A in MDCG 2025-5.
- Developing or distributing software: revisit your qualification, classification, and documentation practices in light of the revised MDCG 2019-11.
- Offering medical apps via online platforms: take steps to ensure your distribution model complies with MDCG 2025-4 and related EU digital regulations.
- Developing AI-based medical devices or IVDs: ensure your design, risk management, and quality system processes support compliance with both the MDR/IVDR and the AI Act, as clarified in MDCG 2025-6.
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