Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)
The European MDR and IVDR legislation is there to ensure optimal traceability in the healthcare supply chain. As of 26 May 2021, new rules on medical devices apply to manufacturers, distributors, importers and healthcare institutions. As of 26 May 2022, the new rules for in-vitro diagnostics (IVDR) apply.
Traceability with UDI
Under legislation, Unique Device Identification (UDI) is required to identify products and make them traceable. When a medical device is used, the UDI is linked to the patient. Information about medical devices is recorded in the EUDAMED database using the UDI and Basic UDI-DI.
EUDAMED
EUDAMED will provide a living picture of the lifecycle of medical devices that are made available in the European Union (EU). It will integrate different electronic systems to collate and process information about medical devices and related companies (e.g. manufacturers). Patients, manufacturers, Notified Bodies and healthcare institutions will also be able to access parts of the database.
Timeline
| Classification | UDI assignment | UDI coding |
|---|---|---|
| Implants and class III | 26 May 2021 | 26 May 2021 |
| Class IIa and llb | 26 May 2021 | 26 May 2023 |
| Class I | 26 May 2021 | 26 May 2025 |
| UDI carrier on reusable devices | 26 May 2021 | + 2 years |
| Class D | 26 May 2022 | 26 May 2023 |
| Class C and B | 26 May 2022 | 26 May 2025 |
| Class A | 26 May 2022 | 26 May 2027 |
Submission of information to EUDAMED was 26 November 2022 for medical devices class III, II and I. And for class D, C, B and A it was 26 November 2023. Since February 2022, there have been changes regarding the mandatory deadlines of EUDAMED. Some modules will be completed later. View the timeline showing the development of the EUDAMED modules.
Risk classes
The MDR distinguishes between different risk classes. The classification is made on the basis of 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.