Introduction: the shift in healthcare AI

This year, debates about AI in healthcare have moved from conference stages into regulatory policy. European health authorities are drawing a sharper line: when AI influences clinical documentation, it is no longer just productivity software. It is a medical device.

For AI scribes, this distinction is critical. If they shape patient records, they can impact patient care. And in Europe, that means they likely fall under the Medical Device Regulation (MDR).

Why MDR needs to cover AI scribes

The rise of large language models has enabled speech recognition in healthcare to enter the next paradigm of AI scribes. These tools do not merely capture speech verbatim but generate structured draft documentation. When such drafts become part of the patient’s health record, the scribe is supporting clinical documentation and thereby falling within the definition of a medical device. Under the MDR, this brings the tool into scope as Class I under Rule 11, provided its intended purpose is limited to administrative support without providing information to take diagnostic or therapeutic decisions. Regulators recognise both the potential benefits and associated risks, and risk management and oversight are therefore required.

Without MDR classification, companies don’t have to follow the rules that ensure medical devices are safe, tested, and continuously monitored. In healthcare, where even small mistakes can affect patient care, leaving that gap unregulated is no longer acceptable.

Regulators have started demanding CE marking

Over the past year, we have clearly seen that European healthcare regulators and authorities have drawn the conclusion that CE marking is required for AI medical scribes. For example, in the UK, NHS England has published adoption guidance for AI-enabled scribing tools, signaling their treatment as Software as a Medical Device (SaMD) in clinical settings and that they need to be registered with the Medicines and Healthcare products Regulatory Agency (MHRA). We also increasingly see across Europe that both public and private care providers have started demanding CE marking for AI medical scribe products.

The role of CE marking in AI healthcare

In Europe, CE marking is the signal that a medical device conforms to the MDR and meets strict requirements for safety and performance. For AI scribes, this matters on several levels:

• The software is subject to post-market surveillance, so issues are detected and resolved quickly.
• Human factors and usability are evaluated, reducing the chance of errors at the point of care.
• Transparency and reporting obligations ensure accountability from the vendor.

For clinicians, CE marking is shorthand for trust. It tells them the AI tool they’re using has been designed, tested, and monitored to the same standard as other devices in the clinic. AI medical scribes can be developed very differently with varying degrees of quality checks and safety mechanisms in place. A CE marking is an external validation that the product has been developed to meet safety and performance requirements.

Why MDR compliance matters for healthcare

Bringing AI scribes under MDR benefits everyone in the healthcare system:

• For clinicians: confidence that their notes are supported by technology built to clinical safety standards.
• For patients: reassurance that their records are documented with oversight, not left to unregulated software.
• For health systems: stronger trust in procurement, smoother adoption, and a framework for long-term accountability.

MDR isn’t about policies, but about making sure AI in healthcare is safe, reliable, and truly supportive of clinical care.

Looking ahead: the future of regulated AI in healthcare

AI will play a growing role in medicine, but regulation will shape how safely it scales. The EU MDR offers a clear framework for separating consumer productivity tools from medical-grade technology.

For AI scribes, the direction is clear. If they form part of the patient record, they need to meet the standards of a medical device. That way, clinicians stay in control and patient safety is never compromised.

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FAQ

Quick answers on AI scribe regulation:

Are AI scribes considered medical devices in Europe?

Not automatically. Under the EU Medical Device Regulation (MDR 2017/745), software qualifies as a medical device based on its intended purpose. If an AI scribe generates or shapes clinical records, it is medical device software and classified under Rule 11 of Annex VIII.

What about in the UK?

The UK position is clear. The MHRA applies the same intended-purpose test as the EU when qualifying and classifying medical devices. NHS England has also published adoption guidance for AI-enabled scribing tools, signaling their treatment as Software as a Medical Device (SaMD) in clinical settings and that they need to be registered with the Medicines and Healthcare products Regulatory Agency (MHRA)..

What does CE marking mean for AI scribes?

CE marking indicates that the product conforms to the MDR and meets applicable EU safety and performance requirements. It also entails obligations for post-market surveillance.

Why should AI scribes be regulated under MDR?

Because they influence patient records and, by extension, care. MDR oversight ensures safety, performance, and accountability of medical devices in clinical use.

How does MDR benefit clinicians using AI scribes?

It gives clinicians confidence that tools are designed, assessed, and monitored to medical-grade standards, with clear intended use, risk classification, and post-market surveillance requirements (MDCG 2019-11 guidance).

What about the new EU AI Act?

Where an AI scribe is classified as a medical device under the MDR, it is high‑risk under the AI Act if the device requires a third‑party conformity assessment (typically Class IIa and above). Class I MDSW, such as an AI scribe, are not high‑risk under the AI Act, though transparency obligations can still apply when interacting with users or generating synthetic content (see Guidance on the interplay between the MDR and AI Act).