The European Commission has released five new guidance documents on the use of unique device identifiers (UDIs). The guidance covers UDIs for systems and procedure packs, definitions and descriptions of formats of the UDI core elements for systems and procedure packs, UDI assignment to medical device software, clarification of UDI responsibilities in relation to Article 16, and provisional considerations regarding language issues associated with the UDI database.
The European Commission states that “system and procedure packs shall be assigned and bear their own UDI (including both UDI-DI and UDI-PI), in accordance with Annex VI, Part C, points 3.7 and 6.3.1. of the Medical Device Regulation (MDR).” The guidance explains the circumstances under which a UDI would be necessary.
With regards to medical device software, which also requires a UDI, the guidance mentions that any change of the basic UDI-DI or any changes which impact the original performance, safety or the interpretation of data or a change to the name or trade name, version or model number, critical warnings or contra-indications or user interface language would require a new UDI-DI. This is to ensure the traceability and correct identification of the medical device software.
Manufacturers, as part of maintenance and post-market surveillance activities, are advised to evaluate the possible impact of any changes to the function of software on the software’s qualification as medical device software, its classification, its intended purpose and essential design and manufacturing characteristics, which could trigger a new basic UDI-DI.
Under Article 16 of the MDR and in-vitro diagnostic medical devices (IVDR), on clarification of UDI responsibilities, the guidance focuses on distributors or importers and ensuring that their operations in establishing a UDI do not “compromise the readability of the UDI carrier and its information identifying the actual device” and that “the specific procedures are part of the distributor’s or importer’s quality management system.”
MDCG 2018-3 – Guidance on UDI for systems and procedure packs.
MDCG 2018-4 – Definitions/Descriptions and formats of the UDI core elements for systems or procedure packs.
MDCG 2018-5 – UDI Assignment to Medical Device Software.
MDCG 2018-6 – Clarifications of UDI related responsibilities in relation to Article 16.
MDCG 2018-7 – Provisional considerations regarding the language issues associated with the UDI database.