Clarifies UDI assignment to Software that is considered a medical device or IVD. IVDR Annex VI Part C 6.2.1 clearly states that only software which is commercially available on its own, as well as software which constitutes a device in itself, shall be subject to UDI requirements.
Clarifies the UDI related responsibilities arising from IVDR Article 16 (1). When a distributor, importer or another natural legal person assumes the role of manufacturer then they also assume all relevant requirements related to UDI (assignment and labelling).
Addresses provisional considerations regarding languages requirements of the UDI database. Core data elements should be accessible to the public and as such should be easily understood by all EU citizens. Of the core data elements, only three (“Additional product description”, “Storage and handling conditions” and “Critical warnings or contra-indications”) are expected to have a free-text format. The input for these fields must be provided in English as well as in all languages where the device is made available. For “Storage and handling conditions” and “Critical warnings or contra-indications” only that information that is required on the label will need to be input in the UDI database.
What does this mean to you?
These documents could provide you with some additional guidance and understanding on how to best approach UDI in your role for your specific products. These guidance documents are not legally binding but simply aim at providing direction and clarity to all relevant stakeholders on how to interpret relevant requirements.
Qarad will continue to monitor all progress and will keep you updated via our Qarad flash.