When your software is a medical device.
Software intended for diagnosis, monitoring, prediction or treatment is a medical device under EU law. Most decision-support software lands in a class that needs a notified body. AI adds the AI Act on top, and that overlap is changing.
A technical view, not legal advice. Facts checked against the official sources below on 1 November 2026.
- Software with a medical purpose for individual patients
- In vitro diagnostic software, under IVDR
- Not general-purpose or well-being software used in healthcare
- 31 Dec 2027 MDR: end of transition for class III and implantable class IIb legacy devices.
- 31 Dec 2028 MDR: end of transition for other class IIb, IIa and some class I legacy devices.
- 2 Aug 2028 AI Act high-risk obligations for AI medical devices.
- Pending A December 2025 proposal to simplify MDR and IVDR, including their link to the AI Act, is in Parliament.
Classification decides almost everything else.
Is it a device?
It is if the manufacturer intends it for a medical purpose for individual patients. Where the software runs does not matter.
Rule 11
Software that informs diagnostic or treatment decisions is at least class IIa, rising to IIb or III if a wrong decision could cause serious or irreversible harm.
Notified body
From class IIa up, a notified body must assess the device. That means clinical evidence, a quality management system and technical documentation.
AI on top
AI medical devices that need a notified body are also high-risk under the AI Act, from 2 August 2028 unless the pending proposal changes that.
From requirement to working system.
The cost of a medical-device project is set early: by the intended purpose you write down, and the evidence you plan to collect.
- Shape the intended purpose and classification before the build
- Validation against clinical reference standards
- Explainability and documentation that serve both MDR and the AI Act
- Privacy-by-design data architecture for patient data
What does this mean for your systems?
Tell us what you build or run. We will give you a straight, technical answer.
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