AI in dentistry is not just productivity software

When AI generates text that becomes part of the patient record, the rules change. It's no longer just about saving time -- it's about patient safety. In Europe, this means AI documentation tools fall under the EU Medical Device Regulation, MDR 2017/745.

Dentio is CE-marked as a Class I medical device. This is not just a legal formality. It is a commitment that every feature, every update, and every note generated is built on systematic safety management.

Why MDR needs to cover AI scribes

Modern AI scribes do more than transcribe speech verbatim. They structure and format documentation drafts based on what the clinician explicitly stated during the patient conversation. When such drafts are reviewed by the clinician and become part of the patient record, the accuracy and completeness of that record matters for patient safety.

Under MDR, software intended for clinical documentation purposes is classified according to Rule 11 in Annex VIII. Dentio is classified as Class I based on the product's intended purpose under Rule 11. The dentist reviews and approves output before it is saved to the record.

Without MDR classification, there are no requirements for systematic risk management, clinical evaluation, or post-market surveillance. In dentistry, where documentation forms part of the patient record, it is essential that AI tools meet regulatory standards for safety and quality.

What CE marking means in practice

CE marking signals that a medical device meets MDR's requirements for safety and performance. For dental professionals using Dentio, this means specifically:

Risk management throughout the lifecycle. CE marking requires the manufacturer to systematically identify and manage risks related to the product -- from transcription errors and hallucinations to language barriers. Dentio fulfils this through risk management according to ISO 14971.

Clinical evaluation based on evidence. The manufacturer must demonstrate that the product is safe and performs as intended. Dentio has conducted a clinical evaluation in accordance with MDR.

Continuous monitoring. After placing a product on the market, a system is required to identify and address problems. Dentio has a post-market surveillance system in accordance with MDR.

Quality management system. All parts of the development process must be governed by documented processes. Dentio has a quality management system in accordance with MDR requirements.

The dentist always has the final word

A fundamental principle in Dentio's design is that AI never makes clinical decisions. The product generates a draft. The dentist reads, edits as needed, and actively approves before anything is saved in the journal system.

This human oversight principle is not just a feature -- it is a regulatory cornerstone. It ensures that clinical responsibility always rests with the licensed healthcare provider, exactly as it should.

Why it matters for your clinic

More and more regions, care chains, and procurement bodies in Sweden and Europe are requiring AI tools in healthcare to be CE-marked. This is a natural development: if software affects patient records, it should meet the same type of requirements as other medical equipment.

For clinics, CE marking provides confidence that the tool used daily has been developed, tested, and monitored according to established safety standards. For patients, it means their records are documented under regulatory oversight, not by unregulated software.

Regulatory information

Dentio is classified as a Class I medical device under EU MDR 2017/745, Rule 11.

UDI-DI: 07350183430006 Basic UDI-DI: 735018343Dentio_v1AM Registered with: Läkemedelsverket (Swedish Medical Products Agency)

Frequently asked questions

Are all AI scribes medical devices in Europe?

Not automatically. Under EU MDR 2017/745, software qualifies as a medical device based on its intended purpose. If an AI scribe generates or shapes clinical documentation, it falls under the definition and is classified according to Rule 11 in Annex VIII.

What does Class I mean?

Class I products are considered lower risk but must still meet MDR requirements for risk management, clinical evaluation, quality management, and post-market surveillance. The manufacturer performs conformity assessment through self-declaration without a notified body.

Why should AI scribes be regulated under MDR?

Because they affect patient records and, by extension, patient care. MDR oversight ensures that tools are safe, perform as intended, and that the manufacturer is responsible for continuous follow-up.

How does the EU AI Act affect AI scribes?

Class I medical devices, like Dentio, are not considered high-risk under the AI Act. However, transparency requirements may apply when interacting with users or generating synthetic content.