Maître Seyed Siavash SHAHRJERDI

Avocat au barreau de Paris

Compétences : Droit de la protection des données personnelles, Droit du numérique et des communications, Droit de la propriété intellectuelle, Droit de l'arbitrage, Procédure d'appel, Droit bancaire et boursier, Droit international et de l'Union européenne, Droit commercial, des affaires et de la concurrence, Droit des assurances

Barreau : Paris

Adresse : 37 AVENUE VICTOR HUGO 75116 PARIS

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Publié le 10/08/2026

IA médicale : le cumul des exigences est confirmé

Article juridique - Droit de la santé

Par Me Seyed Siavash SHAHRJERDI

IA médicale : le cumul des exigences est confirmé

Le Digital Omnibus sur l’IA a franchi sa dernière étape législative le 29 juin 2026.

Les systèmes d’IA intégrés aux dispositifs médicaux restent susceptibles d’être qualifiés à haut risque. Contrairement aux machines, ils n’ont pas été retirés du champ d’application direct d'AI Act.

À partir du 2 août 2028, les fabricants devront donc satisfaire aux exigences propres aux dispositifs médicaux et à celles applicables aux systèmes d’IA à haut risque.

L’évaluation pourra toutefois être intégrée dans une procédure unique auprès d’un organisme compétent.

Trois chantiers doivent commencer maintenant :
→ cartographier les preuves déjà présentes dans le dossier technique du dispositif
→ identifier les compléments nécessaires sur les données, la supervision humaine, la journalisation, la robustesse et la cybersécurité
→ vérifier si l’organisme chargé de l’évaluation du dispositif prépare aussi sa compétence en matière d’intelligence artificielle

D’ici au 2 août 2027, la European Commission pourra limiter certaines obligations lorsque la réglementation médicale garantit déjà une protection équivalente ou supérieure. Cette équivalence ne doit pas être présumée avant l’adoption de ces actes.

Le bon livrable n’est pas deux dossiers parallèles. C’est une matrice unique indiquant quelle exigence est couverte, par quelle preuve, sous la responsabilité de qui et à quelle date elle doit être réexaminée.