EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)

The European legislation for Medical Device Regulation (MDR) or Regulation (EU) 2017/745 & In-Vitrodiagnostic Regulation (IVDR) or Regulation (EU) 2017/746 is there to achieve optimal traceability in the healthcare chain and safe use of medical devices. Medical devices must, based on the legislation, have a Unique Device Identification (UDI). On June 14, 2019, GS1 was designated an issuer for UDI by the European Commission.

Since May 26, 2021, there are new rules for medical devices and these apply to manufacturers, distributors, importers and healthcare institutions. The new rules for in vitro diagnostics (IVDR) will apply from 26, May 2022.

Overview of deadlines per risk class

Medical Device Class (MDR) UDI assign UDI coding on product
Class III & Implants 26 May 2021 2023
Class IIa & IIb 26 May 2021 2025
Class I 26 May 2021 2027
In-Vitrodiagnostic Regulation (IVDR) 26 May 2022 + 2 year
Class D 26 May 2025* 26 May 2025
Class C 26 May 2026* 26 May 2026
Class B 26 May 2026* 26 May 2026
Class A 26 May 2027* 26 May 2027

Delivery of information to EUDAMED was November 26, 2022 for medical devices class III, II and I. And for class D, C, B and A it was November 26, 2023. Since February 2022 there are changes regarding the mandatory deadlines of EUDAMED. Some modules will be delivered later. View the timeline with the development of the EUDAMED modules.

IVDR postponement
Officially, the IVDR will still take effect on May 26, 2022, but that will only apply to new IVDs that are not yet on the market and also to non-sterile class A devices, which do not require the involvement of a notified body.

*With IVDD certification, under the IVDR must be re-certified (by a notified body).

 

Risk classes

Within the MDR a distinction is made between different risk classes. The classification is an estimate of the risk to the patient/client based on the intended purpose of the device as described by the manufacturer. The least risky product is class I and the most risky product is class III. Classes D, C, B, A apply to the IVDR, with D being the highest risk class.

UK

UK regulation National Health Services (NHS)

US

US regulation Food and Drug Administration (FDA)

andere regelgeving

Other regulations