Classificazione MDR e AI Act dell’UE

MDR Classification

Last updated: April 2026

Product Name	Dentio Practice Automation System (DEN-PAS)
Manufacturer	Dentio AB (Org. No. 559498-5136)
Address	Sveavägen 28-30, 111 34 Stockholm, Sweden
Classification	Class I medical device under EU Medical Device Regulation (MDR 2017/745), Annex VIII Rule 11
Software Version	1.7.0
UDI-DI	07350183430006
Basic UDI-DI	735018343Dentio_v1AM
UDI-PI	1.7.0
SRN	SE-MF-000051592
CE Marking	Per Article 20 of MDR 2017/745. No notified body identification number accompanies the CE marking (MDR Article 20(5)).
Registered with	Läkemedelsverket (Swedish Medical Products Agency)

CE marking

Intended Use

Dentio is an AI-assisted administrative documentation tool intended for licensed dentists and licensed dental hygienists. The system drafts clinical documentation – including journal notes, referrals, referral responses, odontograms/status, and periodontal charting – based on what the clinician explicitly states in audio recordings, free text, or PDF source material from a dental encounter.

Dentio does not diagnose, plan treatment, or make clinical decisions. All generated content remains a draft until reviewed and explicitly approved by a licensed dentist or dental hygienist 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 for diagnostic or therapeutic purposes. Dentio does not provide such information:

• Dentio is an administrative documentation tool intended for use by licensed dentists and dental hygienists. It structures clinical information for the patient record.
• The product does not generate diagnostic conclusions or therapeutic recommendations.
• The clinician makes all clinical decisions. Dentio structures the administrative documentation.
• All drafts require review and explicit 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 per ISO 14971 and clinical evaluation
• Systematic incident reporting and complaint handling
• Post-Market Surveillance with regular data analysis
• Technical documentation maintained on an ongoing basis

Istruzioni per l'uso

Legga le istruzioni per l'uso pubbliche del Dentio Practice Automation System (in svedese) →

Le istruzioni per l'uso complete sono disponibili per gli utenti autorizzati all'interno dell'applicazione Dentio in Impostazioni → Informazioni su Dentio. Contattare [email protected] per una copia cartacea gratuita.

Contact

Dentio AB — Legal & Compliance

Sveavägen 28-30, 111 34 Stockholm, Sweden

E-mail: [email protected]

EU AI Act — Assessment

Version 2.0 – April 2026

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.

Under Regulation (EU) 2024/1689 (the EU AI Act), adopted 13 June 2024 and in force since 1 August 2024, Dentio is regarded as an AI system and 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.
• Provides patient-information materials to clinics describing Dentio's role, data flows, and DPO contact details.

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(3) derogation. A system failure cannot reasonably cause significant harm to a person, because every draft is reviewed and, if necessary, amended by the clinician before it becomes part of the official patient record.

Conclusion: Dentio does not qualify as a high-risk AI system and is assessed as a limited-risk AI system under the EU AI Act.

2.2 Overall result

Dentio is a limited-risk AI system: it is subject to the horizontal transparency duties in Chapter IV of the EU AI Act, but not to the AI Act's high-risk obligations (e.g. the conformity-assessment procedure under Articles 43 ff.), which apply to a different category of AI systems. Dentio's MDR status and its AI Act status are separate regulatory questions.

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 Commission publishes delegated acts, implementing acts, or additional guidance under the EU AI Act;
• 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

Sveavägen 28-30, 111 34 Stockholm, Sweden

E-mail: [email protected]

This assessment is based on Regulation (EU) 2024/1689 (the EU AI Act), adopted 13 June 2024 and in force since 1 August 2024. Dentio will reassess and update this document as the Commission publishes delegated acts, implementing acts, or additional guidance.