MDR-luokitus & EU:n tekoälyasetus

MDR Classification

Last updated: March 2026

Intended Use

Dentio is an AI-assisted administrative documentation tool intended for licensed dental professionals. The system listens to patient consultations and generates drafts of clinical notes, referrals, and other administrative documentation.

Dentio does not diagnose, plan treatment, or make clinical decisions. Every draft requires review and approval by a licensed clinician before becoming part of the patient record.

Why Class I?

Dentio processes and structures clinical data intended for inclusion in patient records. Software with this intended purpose falls within the scope of MDR 2017/745 per Article 2(1). Dentio is registered as a medical device with Läkemedelsverket.

Dentio is classified as a Class I medical device under Rule 11, Annex VIII, Chapter III of MDR 2017/745. Rule 11 assigns software to Class IIa or higher when it provides information used to take decisions with diagnostic or therapeutic purposes. Dentio does not provide such information:

• Dentio is an administrative documentation tool intended for use by licensed dental professionals. It structures clinical information for the patient record.
• The product does not generate diagnostic conclusions or therapeutic recommendations.
• The clinician authors all clinical decisions. Dentio structures the administrative documentation.
• All output requires review and approval by a licensed clinician before entering the patient record.

Quality Management and Post-Market Surveillance

Dentio maintains a quality management system in accordance with MDR requirements, including:

• Risk management and clinical evaluation
• Systematic incident reporting and complaint handling
• Post-Market Surveillance with regular data analysis
• Technical documentation maintained on an ongoing basis

Contact

Dentio AB — Legal & Compliance

Norrtullsgatan 6, 113 29 Stockholm, Sweden

E-mail: [email protected]

EU AI Act — Preliminary Assessment

Version 1.0 – May 25, 2025

1 Application of the AI Act

1.1 Does Dentio constitute an "AI system"?

Dentio is a cloud service that:

• converts recorded speech to text via an automated speech-to-text model; and
• employs a Large Language Model (LLM) to draft administrative documents (journal notes, referral letters, summaries) from that transcript.

Both components process input data to generate structured output for pre-defined objectives, so Dentio falls within the broad definition of an AI system in Article 3(1) of the Act.

Dentio operates with limited autonomy: it never executes actions beyond producing a draft for human verification, and output is never self-deployed into the electronic health record (EHR) without explicit user approval.

Additionally, Dentio processes special-category health data (Article 9 GDPR). A heightened precautionary approach therefore applies: all training/evaluation data are fully pseudonymised; role-based access controls limit engineers who can view raw transcripts; and every access event is logged.

Given the legislator's broad wording and the absence of final guidance, Dentio assumes the service may be regarded as an AI system and proactively applies the relevant obligations.

1.2 Transparency obligations (Article 50)

Because Dentio records natural-language conversations between dental professionals and patients, individuals interact - albeit indirectly - with an AI system. Article 50 therefore requires notifying them that AI is involved. Dentio:

• Supplies template briefing text, chair-side posters and consent-script language for clinics.
• Requires users, before each recording, to confirm that informed patient consent has been obtained; the confirmation is timestamp-logged.
• Publishes a patient-facing web page explaining Dentio's role, data flows and DPO contact details.
• Provides a 15-minute e-learning module for clinic staff covering workflow, consent and data-protection duties (updated annually).

2 Risk Classification

2.1 Assessment against the high-risk categories (Articles 6 & 8)

Annex II (harmonised legislation). Dentio is classified as a Class I medical device under MDR 2017/745 and is CE-marked accordingly. However, because Dentio serves purely administrative purposes and offers no diagnostic or therapeutic recommendation, it does not fall within the high-risk medical-device categories listed in Annex II of the AI Act.

Annex III (listed high-risk use cases). Dentio does not evaluate patient eligibility, triage or resource allocation; drafts remain under clinical control.

Article 6(2) fallback test. A system failure cannot reasonably significantly harm a person, because every draft is reviewed and, if necessary, amended by the dentist before entering the official record.

Conclusion: Dentio does not qualify as a high-risk AI system. Section 2.2 of Dentio's Terms of Service classifies it as a limited-risk AI system.

2.2 Overall result

Dentio is a limited-risk AI system: it must meet the horizontal transparency duties in Chapter V, but is exempt from conformity assessment, CE-marking and quality-management-system obligations reserved for high-risk AI.

3 Dentio's Compliance Measures for Limited-Risk Systems

4 Governance & Continuous Review

Dentio's security and compliance steering group reviews this assessment at least annually or when:

• the EU AI Act or delegated acts are finalised;
• Dentio introduces material new functionality (e.g., new data processing categories or significant changes to output types); or
• a significant incident or regulatory interpretation warrants re-classification.

Updates are communicated to all customers whenever their obligations change.

5 Contact

Dentio AB – Legal & Compliance

Norrtullsgatan 6, 113 29 Stockholm, Sweden

E-mail: [email protected]

This analysis is based on the draft political agreement of the EU Artificial Intelligence Act as of May 25, 2025. The legal environment remains fluid; Dentio will reassess and update this document once the final text, delegated acts or Commission guidance are available.