Published on October 10, 2018 by the Medical Devices Coordination Group (MDCG), five guidelines provide insights on the implementation of the UDI (Unique Device Identification) in accordance with the MDR (EU) 2017/745 and IVDR (EU) 2017/746.
In particular, the guidelines address the following topics:
- Sistema and procedure packs: UDI assignment and related information that the Manufacturer must provide to the EUDAMED database, in accordance with Article 29 (2) and Annex VI Part B of the MDR;
- Medical Device software : specific considerations for the classification of the software as a medical device (only software which are commercially available on their own and stand-alone software are subject to UDI requirements) and subsequent UDI assignment;
- Economic operators responsibility regarding UDI in relation to Article 16 (1) of the MDR and IVDR, providing clarifications on situations where the obligations of the Manufacturer apply to the Importer, the Distributor or any other person;
- Language issues associated with the UDI database in relation to Annex VI Part A, Section 2 and Part B of the MDR and IVDR, offering provisions that make the entered information accessible to the public and easy to interpret.
The aforementioned documents follow the first guidelines on the nomenclature of Medical Devices and UDI published last April.
