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

The European legislation for Medical Device Regulation (MDR) (EU) 2017/745 & In-Vitrodiagnostic Regulation (IVDR) (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).

The timeline for mandatory use of EUDAMED is known.

• 28 May 2026: Mandatory publication of new medical devices and system and procedure packs.
• 28 November 2026: End of the transition period for medical devices and system and procedure packs placed on the market before 27 May 2026.

View the timeline with the development of the EUDAMED modules.

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Risk classes for MDR and IVDR

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.

Overview of deadlines per risk class

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