EU MDR and the AI Act (Annex I medical devices)

What it is

Regulation (EU) 2017/745 is the Union medical-devices regulation. The Commission AI Act Service Desk Annex I, based on the EUR-Lex consolidated AI Act as at 27 July 2026, still lists Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices as Section A item 11.

The AI Act classifies some systems as high-risk under Article 6(1) and Annex I. High-risk Chapter III, Sections 1–3 apply from 2 August 2028 for systems classified under Article 6(1) and Annex I, after the Digital Omnibus dates already cited on the EU AI Act explainer.

The Service Desk marks Section A item 1 as DELETED / Not present after the amendment. Item 11 (MDR) is still present on that page.

What it is not

This page is not a claim that MDR and the AI Act are one certificate. We have not found an official Commission sentence that says listing MDR in Annex I replaces a notified-body MDR assessment or that it is an IEC 62304 process. FDA PCCP guidance is a different jurisdiction.

How it relates to other frameworks

• EU AI Act. Organizational and high-risk AI-system rules. This explainer is the medical-device Annex I intersection only.
• IEC 62304. Software life-cycle standard. Not Union law.
• FDA AI-DSF / PCCP. US marketing submissions. Not MDR.

Primary sources

Read Regulation (EU) 2017/745 and Annex I on the AI Act Service Desk.