Building off guidance released in March, the European Commission this month unveiled five new guidance documents on the use of unique device identifiers (UDIs).
The guidances deal with 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.
In addition to defining systems and procedure packs, the EC notes, “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 MDR [Medical Device Regulation].” The guidance goes on to explain the circumstances under which a UDI would be necessary.
For medical device software, which also require a UDI, the guidance notes 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 guarantee the traceability and correct identification of the medical device software,” the EC says.
“As part of their maintenance and post-market surveillance activities, manufacturers should 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, as that could trigger a new Basic UDI-DI,” the guidance notes.
On the clarification of UDI responsibilities under Article 16 of the MDR and IVDR, the guidance homes in on distributors or importers and ensuring that their operations in establishing a UDI “in no way 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.”
And the guidance on language issues deals with, among other factors, ensuring the information in the UDI database is publicly available and easily understandable by any European citizen.
- Guidance on UDI for systems and procedure packs
- Definitions/Descriptions and formats of the UDI core elements for systems or procedure packs
- UDI Assignment to Medical Device Software
- Clarifications of UDI related responsibilities in relation to Article 16
- Provisional considerations regarding the language issues associated with the UDI database