MDR/IVDR: obligations and deadlines

Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)

In forceMDR/IVDR

Summary

Software with a medical purpose, including diagnostic or triage AI, is a medical device. It needs clinical evaluation, risk management, a quality system and, depending on its class, a notified body certificate. Guidance MDCG 2025-6 explains how it fits with the AI Act.

Who it applies to

Manufacturers, importers and distributors of AI medical devices; hospitals making in-house devices.

Penalties

Set by each Member State.

Official name: Reglamento (UE) 2017/745 sobre los productos sanitarios y Reglamento (UE) 2017/746 sobre los productos sanitarios para diagnóstico in vitro
Official reference: Reglamentos (UE) 2017/745 y 2017/746, DO L 117 de 5.5.2017; aplicables desde el 26.5.2021 y el 26.5.2022
Regulator: National health product authorities (AEMPS in Spain) and notified bodies
Official source: Check the sourceHow we verify sources

Key dates

May 26, 2021MDR applies
May 26, 2022IVDR applies
June 19, 2025MDCG 2025-6 guidance on MDR/IVDR and the AI Act

Obligations and dates

Obligations table
Obligation	Article or citation	Status	Date	Who it applies to	Verification
Clinical evaluation and technical documentation for AI medical software	Reglamento (UE) 2017/745, arts. 10, 52, 61 y Anexo II; Reglamento (UE) 2017/746; MDCG 2025-6	In force	Already applicable	If you develop or sell software or AI with a medical purpose (diagnosis, triage, clinical support).	Verified in the official source on October 31, 2026

Clinical evaluation and technical documentation for AI medical software

Reglamento (UE) 2017/745, arts. 10, 52, 61 y Anexo II; Reglamento (UE) 2017/746; MDCG 2025-6In force

Already applicable

When it relates: If you develop or sell software or AI with a medical purpose (diagnosis, triage, clinical support).
What the rule provides: Classify the software under MDR or IVDR rules and follow the applicable conformity assessment.
Clinical or performance evaluation with data representative of the intended population.
Quality management system and technical file, ready to integrate AI Act requirements (Aug 2, 2028).
Post-market surveillance, including model changes after updates.
Typical evidence: Technical file and clinical evaluation.
Notified body certificate.
Related base documents: Clinical and Technical Validation Protocol for Healthcare AI
Supporting documents: Model Card
AI Post-Deployment Monitoring Plan
AI Risk Management Procedure
Dataset Datasheet
Verification: 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.