EU Medical Device Regulation (MDR)

On 14 June 2019, GS1 was designated by the European Commission as the issuer of Unique Device Identifiers (UDI).
This standardised way of uniquely identifying medical devices is part of the Medical Device Regulation (MDR) or Regulation (EU) 2017/745 & in vitro diagnostic medical devices (EU) 2017/746 adopted on 5 April 2017. 

As a result of the COVID-19 pandemic, on 24 April 2020, the application date was postponed to 26 May 2021 for regulation 2017/745, instead of the initial date of 25 May 2020. This gives the various actors more time to comply with the regulation.
For in vitro diagnostic medical devices (2017/746), the date remains unchanged at 25 May 2022.
We refer to the FAGG for detailed information on changes and unchanged provisions.

Based on information from the FAGG regarding the UDI, medical devices must have a UDI (Unique Device Identifier) as of 26 May 2021. 

This obligation is described in Article 27 of the Regulation for medical devices and Article 24 for in vitro diagnostic medical devices.

The deadline for correctly wearing a recognised UDI on the device, the label and the higher packaging levels are unchanged and depend on the risk class to which the device belongs. 

Overview Deadlines per risk class

  Deadline on May 26th If reusable (*) May 26th
MD Class III & Implants  2021 2023
MD Class II a&b 2023 2025
MD Class I 2025 2027
IVD Class D 2023  
IVD Class B&C 2025  
IVD Class A 2027  

(*) For reusable medical devices (e.g. instruments to be sterilised), there will be an obligation (with exceptions) to affix the UDI to the device itself, known as direct part marking. There is an extended deadline for this.