Jun 13, 2019

The European Commission has designated four organizations as Unique Device Identification (UDI) Issuing Agencies to support medical device and IVD manufacturers comply with new regulatory requirements.

UDI issuing agencies

The Official Journal of the European Union (OJEU) of 7 June 2019, page 75, has announced the UDI issuing agencies applicable for Medical Devices under the Medical Devices Regulation (EU) 2017/745 (MDR) and In-Vitro Diagnostic Medical Devices (EU) 2017/746 (IVDR). These agencies will issue the unique codes necessary for UDI, described in MDR articles 27-28, Annex VI and IVDR articles 24-25, Annex VI. UDI will be used on the Declaration of Conformity, Certificates, labels and for identification during distribution, use, incidents and Field Safety Corrective Actions (FSCA). This assignment will become effective on June 27, 2019 and will be valid for five years, after which designations will be reviewed by the European Commission and possibly renewed.

One European UDI issuing agency

Of the four UDI issuing Agencies designated by the European Commission, only one, Informationsstelle für Arzneispezialitäten (IFA GmbH), is based in Europe. This German organization is currently focusing on the identification of medicinal products. The other identified agencies are already active for US FDA UDI. They are:

  • GS1 AISBL
  • Health Industry Business Communications Council (HIBCC)
  • ICCBBA

Use of UDI

The Basic UDI-DI will be the code that identifies the dataset in Eudamed that describes the device. The Basic UDI-DI will be on the Declaration of Conformity and Certificate. Higher UDI-DI will be on the device label. This will allow for one UDI that can be used on the label of a device worldwide, even though the data elements in national databases may vary from market to market. These higher UDI-DI designations will identify devices at the packaging level.

Systems and Procedure Packs

This also means that if a company puts different products into a box that will be placed on the EU market, that box needs to have an extra UDI assigned. This is for example the case when a manufacturer distributes a combination of a catheter and pouches in a single box. According to definition 10 or 11 (depending on the exact intended purpose) this company is now acting as a Systems or Procedure Pack Producer and needs to request a Single Registration Number for Eudamed. Only then can the firm assign this UDI to this system or procedure pack.

Additional UDI and European medical device regulatory resources:

European CE Marking strategy for medical devices
European CE Mark consulting for IVD manufacturers
EU MDR gap assessment and transition strategy for medical device manufacturers
Webinar: Europe’s Medical Devices Regulation (MDR)
Whitepaper: Understanding the new Eudamed