EU 2017/745 (MDR) for medical devices

Regulation (EU) 2017/745 on medical devices, the MDR for short, has governed since May 2021 the conditions under which a medical device may be placed on the market in the European Union. For all devices above class I — and for class I devices supplied sterile, with a measuring function or classed as reusable surgical instruments — a notified body must confirm conformity. The result is an EU certificate under the MDR.

Depending on the conformity assessment route, these are different certificates: the certificate covering the quality management system and the assessment of technical documentation under Annex IX, the type-examination under Annex X, or production quality assurance under Annex XI. A certificate is valid for at most five years and is surveilled at least annually, including unannounced audits.

For buyers, the decisive question is who holds the certificate. It is tied to the manufacturer that places the device on the market under its own name — not to the supplier that produces it. A contract manufacturer generally needs no MDR certificate of its own but a quality management system to ISO 13485. Anyone stating "EU 2017/745 (MDR)" in this directory should be able to present a certificate issued by a notified body.