The Medical Device Coordination Group (MDCG), an expert committee of the European Union, published new documents on medical software in June 2025.
The Updates at a Glance
- MDCG 2025-4: Guidance on the safe making available of digital health applications on online platforms
- MDCG 2025-5: Guidance on requirements for performance studies for in vitro diagnostic medical devices under EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR)
- MDCG 2019-11 Rev.1 (2025): Updated version of the guidance on the qualification and classification of software under EU Regulation 2017/745 on medical devices (MDR) and IVDR
Please note that the the MDCG currently provides their orientation documents in English language only.
Please note that the changes listed are based on our editorial selection and are not exhaustive.
The experts at BEO BERLIN are available to answer any questions you may have and provide advice. Write to us your enquiry – we will be happy to advise you.
An Overview of the Changes
The first document, MDCG 2025-4, contains regulatory requirements for providers of app developer platforms that host or provide medical software (MDSW).
Responsibilities are divided into two categories for providers of app developer platforms:
- As an intermediary in accordance with the EU Digital Services Act (DSA) – in this case, the platform provider is only the host of the MDSW. The provider is only subject to the DSA, not to the obligations of an economic operator under the MDR.
- A platform provider is considered an importer or distributor if it is the legal owner of the medical software. It is irrelevant whether the product is sold to end customers or is freely available. In this case, the provider is subject to the obligations of the DSA and the MDR.
The second document, MDCG 2025-5, explains the regulatory framework for in vitro diagnostic medical devices. The most notable change is the functional distinction between analytical performance studies and clinical performance studies. While analytical studies determine measurement accuracy and detection limits, clinical studies aim to demonstrate the correlation of test results with a clinical condition. The relevant legal basis is the IVDR.
The third document, MDCG 2019-11 Rev.1 (2025), is the revised version (Rev. 1) of a 2019 guidance document that sets out the requirements for quality records and classification of medical software.
The main changes are:
- Clarification of the scope of application of the document
- Clarification of specifications and formulation of the intendet use
- Introduction and definition of modular medical software
- Various extensions and restrictions of definitions, mainly concerning the term ‘software’
- Examples of the changes mentioned
Medical Software on the Rise – Legislators Follow Suit
From telemedical consultations to therapy apps for early skin cancer detection, medical software is booming. And so it is only natural that regulatory authorities are not sitting on their hands, but are actively adapting legislation.
Unfortunately, the implementation of these regulations often backfires on manufacturers, hindering innovation and market access. Bureaucratic burdens can paralyse companies, delay market entry and cause good inventions to disappear under the carpet. Safety and speed are in obvious competition here.
But BEO BERLIN is here to help manufacturers reduce this burden!
Our team of regulatory affairs experts is highly knowledgeable, enabling us to work with you, the manufacturer, importer or distributor, to achieve speed and security!
So that your medical device – whether it be analogue or digital – may safely hit the market!
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