In our last post, we explained why AI scribes need to fall under the EU’s Medical Device Regulation (MDR). That shift matters because once software shapes patient records, it directly affects care.

Now we’re looking at what MDR compliance means in practice. Tandem’s AI scribe is officially CE marked as a medical device under MDR. For clinicians, that certification is more than a legal box to tick. It is a safeguard that every note and every feature is designed, tested, and monitored to the same standards as the other trusted tools in the clinic.

When AI shapes medical records, it stops being productivity software. In Europe, that makes it a medical device, and subject to Medical Device Regulation (MDR 2017/745).

MDR as the strictest medical device regulation

The EU MDR is widely recognised as the most rigorous medical device framework in the world. It covers any software that generates or shapes medical records used in care, classifying it under Rule 11 of Annex VIII.

For AI scribes, this distinction is critical. If the software produces notes that become part of the patient file, it influences diagnosis and treatment. MDR ensures that such tools are subject to strict evaluation, risk management, and post-market surveillance.

Tandem as a CE marked medical device

Tandem’s AI medical scribe is officially CE marked as a Class I medical device under EU MDR. This recognition confirms that Tandem is regulated healthcare technology, not unregulated productivity software.

• Registered with the Swedish Medical Products Agency (valid across EU). Tandem is listed with the Swedish Medical Products Agency as a manufacturer of CE marked medical devices.
• Registered with the UK Medicines and Healthcare products Regulatory Agency (MHRA). Tandem is also registered in the UK, ensuring compliance for clinicians practicing under UK regulations.
• Designed for clinicians. Every feature is shaped by usability principles that prioritise safety and reduce risk at the point of care.

What CE MDR certification means in daily practice

Certification is not abstract. It affects how clinicians work every day.

• Support for accuracy and efficiency. Tandem streamlines documentation while keeping responsibility with the licensed professional.
• Quality-first development. Our quality system is centred on patient safety, continuous monitoring, and post-market surveillance.
• Transparency and accountability. Clinicians can report incidents directly to national agencies, ensuring oversight beyond the company itself.

Why MDR compliance matters for healthcare AI

AI scribes are expanding quickly, but not all are regulated. MDR compliance is the difference between consumer productivity tools and medical-grade technology.

• For clinicians: confidence that their notes are supported by regulated tools designed for safety.
• For patients: assurance that their records are documented with oversight, not left to unmonitored software.
• For health systems: trust in procurement and a framework for long-term accountability.

By aligning with MDR, Tandem shows that AI in healthcare can scale responsibly, keeping clinicians in control and patient safety at the centre. AI medical scribes can be developed very differently with varying degrees of quality checks and safety mechanisms in place. MDR provides an external validation that the product has been developed to meet safety and performance requirements.

How the EU AI Act adds another layer of protection

MDR is the foundation for medical device safety in Europe. But with the adoption of the EU AI Act (Regulation (EU) 2024/1689), AI scribes classified as medical devices are now also recognised as high-risk AI systems.

This creates a dual framework:

• MDR ensures clinical safety. It governs risk classification, usability, and post-market surveillance.
• The AI Act ensures trustworthy AI. It adds requirements for data quality, transparency, human oversight, and risk management.

Together, they mean AI scribes like Tandem are regulated both as medical devices and as high-risk AI systems. For clinicians, that’s an extra guarantee that safety, transparency, and accountability are never optional.

A trusted choice for clinicians in Europe

MDR sets the foundation for safe medical devices. The EU AI Act adds another layer, making AI scribes like Tandem high-risk AI systems with additional obligations for transparency, oversight, and accountability.

Together, these frameworks make sure AI in healthcare develops safely and responsibly. For clinicians, the takeaway is simple: Tandem is not just helpful. It’s a regulated, reliable medical device you can trust every day.

If you want to understand why AI scribes must fall under MDR in the first place, see our earlier post: Why AI scribes need to fall under EU MDR.

FAQ

What does CE marking mean for AI scribes?

CE marking shows that a medical device meets EU MDR requirements for safety and performance. It also triggers post-market monitoring, giving clinicians ongoing protection.

What is a Class I medical device under MDR?

Class I devices are considered low risk but must still meet MDR standards. AI scribes like Tandem fall under this category when they generate clinical records without replacing clinical judgment.

Why does MDR compliance matter for AI in healthcare?

Because AI scribes directly influence patient records and care. MDR oversight ensures they are safe, transparent, and accountable – with requirements for usability, monitoring, and incident reporting.

How does the EU AI Act apply to AI scribes?

If an AI scribe is classified as a medical device, it is also a high-risk AI system under the EU AI Act. This means extra obligations for transparency, human oversight, and data quality, alongside MDR compliance.

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