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 coding UDI