EU 2017/746 (IVDR) for medical devices

Regulation (EU) 2017/746 on in vitro diagnostic medical devices, the IVDR for short, has applied since May 2022 and has changed the sector more profoundly than the MDR changed medical devices. Under the old directive only a small share of diagnostics needed a notified body; under the IVDR it is the large majority. The reason is the new risk-based classification into classes A to D: from class B upwards — which includes, for example, pregnancy and cholesterol tests for self-testing — and for sterile class A devices, a notified body confirms conformity and issues an EU certificate.

As with the MDR, the certificate is tied to the manufacturer that places the device on the market under its own name. Laboratories in health institutions that make their own tests and use them only in-house are subject to special rules under Article 5(5); they need no certificate for this. Suppliers of reagents, components or housings generally work with a quality management system to ISO 13485.

For buyers the same applies as with the MDR: anyone stating "EU 2017/746 (IVDR)" in this directory should be able to present a certificate issued by a notified body. A certificate under the old Directive 98/79/EC is not an IVDR certificate, even if it remains valid for a transitional period.