root@fr:~$ lexique/dispositif-medical

Dispositif médical (logiciel)

Compliance and law

Under EU Regulation 2017/745 (MDR, Rule 11), software providing information used for diagnostic or therapeutic decisions is a medical device, requiring CE marking at class IIa or above. Documentation and administrative software is not one; qualifying as a medical device also pulls the system into the AI Act high-risk category.

Also called DM logiciel, Software as a Medical Device, SaMD

Related terms

Données de santé

Compliance and law

A special category of personal data under Article 9 GDPR, whose processing is prohibited in principle outside strictly framed exceptions. In practice it...

Supervision humaine

Governance

A pattern where a human reviews, corrects or approves an agent decisions before they take effect. It is mandatory on sensitive decisions: AI augments the...

Garde-fous

Governance

Safety mechanisms that frame what an agent can do and answer: input filtering, output validation, business rules and action limits. They turn raw capability...

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