MedTech Europe information leaflet on UDI and implant card availability

Posted on 02.12.2021

The aim of this information leaflet is to explain the transition timeline for when the Unique Device Identifier (UDI) information and the implant cards can be expected to be supplied with medical devices under the Medical Devices Regulation (EU) 2017/745 (MDR), to help health institutions navigate in the new legislative environment and comply with any arising legal requirements.

The MDR has applied since the 26 May 2021. To avoid market disruption and to allow a smooth transition from the Medical Device Directives (AIMDD – 90/385/EEC and MDD – 93/42/EEC) to the MDR, several transitional provisions are in place, including allowing devices CE marked under the Medical Device Directives to continue to be received by the health institutions until 26 May 2025 and used beyond that time. Devices certified under the AIMDD/MDD and under the MDR may coexist on the market. Therefore both, AIMDD/MDD (without UDI or an implant card) and MDR (with UDI and an implant card) certified devices can continue to be received by health institutions until 26 May 2025.