Diagnosis, triage or clinical support in Spain: related rules
AI that helps diagnose, prioritize patients, recommend treatments, read medical images or draft clinical notes. Errors affect health, so clinical validation, medical oversight, patient transparency and, if it is a medical device, sanitary registration are required.
Medical device regulation (AEMPS) and GDPR for health data.
Obligations related to this use case
Using high-risk systems: human oversight, logs and monitoring
AI ActReglamento (UE) 2024/1689, art. 26(1)-(6) y (8)-(12); Anexo III; art. 6(1) y Anexo I; art. 113Adopted, applies later
Applies from December 2, 2027
Deadlines by profile
: Annex III high-risk systems
: Clinical AI that is a high-risk medical device (Annex I)
When it relates
If you use AI for hiring or managing staff, monitoring workers, credit scoring, life or health insurance pricing, student assessment, biometrics or access to public benefits (Annex III). Also, from Aug 2, 2028, if you use clinical AI that is a medical device subject to notified-body assessment (Annex I).
What the rule provides
Use the system according to the provider's instructions.
Assign human oversight to people with enough competence, training, authority and support.
Ensure input data under your control is relevant and representative.
Monitor operation, suspend use when risks appear, and report serious incidents to the provider and the authority.
Keep automatically generated logs under your control for at least six months.
Public bodies: register the use in the EU database. Systems already in use by public authorities: deadline Aug 2, 2030.
Typical evidence
Appointment and training records of human overseers.
Verified in the official source on November 2, 2026Date checked in consolidated Article 113(c)(i) (Dec 2, 2027 for Annex III). Regulation (EU) 2026/1744 moved the date but not the content of Article 26.
AI in regulated products (Annex I): medical devices, machinery, toys, vehicles
AI ActReglamento (UE) 2024/1689, art. 6(1) y Anexo I; art. 113(c)(ii)Adopted, applies later
Applies from August 2, 2028
When it relates
If you make or sell regulated products where AI is a safety component or the product itself (for example, medical software, machinery or vehicles) that require third-party conformity assessment.
What the rule provides
Integrate AI Act high-risk requirements into the sector conformity assessment (for example, under the medical devices regulation).
Keep a single technical file and an integrated quality management system.
Since 2026, convenience or optimization features count as safety components only if their failure endangers health or safety.
Verified in the official source on November 2, 2026Date checked in consolidated Article 113(c)(ii) (Aug 2, 2028). The narrower safety-component definition and the move of the Machinery Regulation to Annex I Section B come from secondary sources.
Verified in the official source on October 31, 2026Application dates are set in the regulations themselves (EUR-Lex). MDCG 2025-6 content taken from law firms (Hogan Lovells, NSF); the guidance was drafted under the earlier AI Act timeline (2027), now 2028.