In Force Checked October 24, 2026
Regulation (EU) 2023/607 extended the transition for qualifying legacy devices to December 31, 2027 (class III and implantable class IIb) and December 31, 2028 (other classes), subject to conditions.
What It Covers
The essential safety and performance requirements every device placed on the EU market must meet, in three chapters: general requirements, design and manufacture, and the information supplied with the device.
Who It Applies To
Every manufacturer placing medical devices on the EU market, whatever the class.
Key Requirements
- General requirements 1 to 9: safety, performance, and risk management across the life cycle.
- Design and manufacture requirements 10 to 22, including chemical, biological, software, electrical, and usability aspects.
- Requirements 23 on labels and instructions for use.
- Conformity shown through a GSPR checklist in the technical documentation (Annex II), using harmonized standards or common specifications where they exist.
What an Auditor Asks to See
- The GSPR checklist, with each requirement marked applicable or not, and why.
- For each applicable requirement, the evidence and the standards applied, by edition.
- Evidence that the checklist was revisited after design changes.
Where Systems Fall Short
- “Not applicable” entered without a justification.
- Standards cited without an edition, or by a withdrawn edition.
How QES Helps
GSPR checklists rebuilt with edition-specific standards and real evidence references.
Related Standards
Sources. EUR-Lex — Regulation (EU) 2017/745 on medical devices (opens in a new tab); EUR-Lex — Regulation (EU) 2023/607 (transition extension) (opens in a new tab). Status checked October 24, 2026. This page summarizes EU MDR Annex I; it does not reproduce or replace it. Buy the standard from its publisher, or read the regulation in its official text, before relying on a detail. Not legal advice.