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 coding UDI
| Classification Medical Device / IVD | UDI coding at packaging |
|---|---|
| Implants and class III | 26 May 2021 |
| Class IIa and llb | 26 May 2023 |
| Class I | 26 May 2025 |
| Reusable devices | + 2 years (UDI on product) |
| Class D | 31 December 2027 |
| Class C | 31 December 2028 |
| Class B and A | 31 December 2029 |