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||MDR Placing UDI-carriers on the labels of devices||Direct marking of the reusable devices|
|Class III & Implants||26 May 2021||26 May 2021||26 May 2023|
|Class IIa & IIb||26 May 2021||26 May 2023||26 May 2025|
|Class I||26 May 2021||26 May 2025||26 May 2027|
|In-Vitrodiagnostic Regulation (IVDR)||UDI assign||IVDR Placing UDI-carriers on the labels of devices|
|Class D||26 May 2022*||26 May 2023|
|Class C||26 May 2022*||26 May 2025|
|Class B||26 May 2022*||26 May 2025|
|Class A||26 May 2022*||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 June 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.
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).
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.