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.

GS1 provides first aid for UDI

As a manufacturer of medical devices, what exactly do you have to do to be in order for the UDI? We put it all together for you.

According to the MDR, manufacturers must place a UDI (identification code) on all medical device packaging and, in some cases, on the medical device itself. In addition, product data must be compulsorily included in Eudamed, the central European database. A Basic UDI must also be assigned to identify a product family.

We recommend that you provide all your medical devices with a UDI as soon as possible so that hospitals can scan your products. 

Follow our 10 Step Plan

  1. Become a member of GS1 so that you can create identification numbers for your articles and locations.

  2. Assign UDI's (Unique Device Identifiers) to each version or model of the medical device.   

    See also the FAQ by the EU Commission

  3. Identify persons within your organisation who are responsible for entering and publishing data.
  4. Assign a GS1 location code (Global Location Number) to your organisation.

  5. Identify product models and/or product families with a Basic UDI.

  6. Place a barcode on the products. Use a GS1 DataMatrix or a GS1-128.

  7. Collect all necessary article data using the field list. This also states which information is required by the MDR. Not yet fully known.

  8. Connect to GS1 GDSN/CDB, the central place to publish article data to your customers. And later to EUDAMED as soon as it is available.

  9. Enter the article data in My Product Manager) and publish it to your customers.

  10. Apply for an SRN (Single Registration Number) to access EUDAMED as soon as it is available.