The Medical Devices Coordination Group (MDCG) endorsed 4 new documents related to UDI.
1. UDI & Software
As a standard rule, new UDI-DI should be affixed whenever the change could lead to mis-identification, and/or ambiguity in the traceability of a device. This could result from a change in trade name, device model/version, critical warnings and contra-indications, (user interface) language,..
In addition to the above “basic” need to change UDI-DI, new UDI-DI for a software is required when a modification touches original performance, safety or interpretation of data. New UDI-DI would therefore be needed in case of modified algorithms, operating platforms, user interfaces,..
Nevertheless, minor software revisions and bug fixes for ex. only require a new UDI-PI.
2. UDI & Systems and Procedure Packs
The producer of a system or procedure pack shall apply for registration as a system or procedure pack producer and obtain a SRN.
System and procedure packs shall be assigned a Basic UDI-DI and producer shall provide it to the UDI database together with the other core data elements.
X-ray systems (“System”) or first aid kit (“procedure pack”) can have same Basic UDI-DI if composed of same group of components and have same intended purpose (even if components are produced by several, different manufacturers).
3. UDI related responsibilities and repackaging/relabelling by the importer, distributor under:
Article 16(1) MDR: Apply for registration as Manufacturers, receive a SRN, apply for the appropriate conformity assessment procedure and feed and provide UDI-product registration.
Article 16 (2), (4) of MDR: Modification (translation of labelling , repackaging) of a device already placed on the market should not compromise the readability of the UDI carrier and its information identifying the device. Additionally, these procedures should be part of the distributor’s or importer’s QMS.
4. In provisional considerations regarding language issues related to UDI, the MDCG concluded that for “free-text” data fields of the UDI database, information shall be provided in English and any other language of a Member State, where the device is made available.
“Free-text” data fields concern storage and handling conditions, critical warnings or contra-indications and additional product description (optional). For the first two data fields, usage of symbols as an alternative to the “free-text” is under consideration.
The European Commission also explores the idea for the EUDAMED to provide List of CMR Substances, as well as a creation of an official database of endoctrine distruptor substances.