Recommendations for European UDI System Released
European Commisioners have published recommendations for an EU-wide Unique Device Identification (UDI) system in the Official Journal of the European Union.
It is anticipated that the eventual EU UDI system as well as the US Food and Drug Administration’s soon-to-be-released UDI system will resemble the International Medical Device Regulator Forum’s (IMDRF) recommendations.
The scope of the recommendation covers medical devices, active implantable medical devices and IVDs.
European Commissioners recommend developing a single UDI system harmonized across the EU, and that any member state pursuing its own UDI system builds in compatibility to the eventual Union-wide system. Furthermore, any member state developing its own UDI system should follow a risk-based approach corresponding to device classification, and implement the system in phases, starting with highest-risk products.
The recommendations also indicate what different participants in the medical device and IVD industries should do to support a UDI system:
- Manufacturers should allocate UDIs to the devices they produce; provide required data for inclusion in the EU UDI database; print UDI codes on their device labels and/or packaging; maintain electronic records of device identifier and production identifier data; and keep track electronically of institutional or professional customers to whom they’ve supplied their device.
- Importers should verify that manufacturers have properly assigned UDIs to devices before going on the EU market; ensure that devices have already been registered in the UDI databases of the member states where the devices are sold; and keep electronic records of identifier data as well as device suppliers and customers.
- European Authorized Representatives should have access to their clients’ device and production identifier data.
- European Distributors should ensure that their manufacturer and/or importer clients have assigned UDIs to their devices; keep electronic records of UDI data associated with devices they distribute; and also keep records of who supplied them with devices as well as which organizations they themselves have supplied those devices.
- Health Institutions should maintain electronic records of UDI information for all medical devices used in their facilities; link high-risk devices to patients those devices treat; and store UDI information for implantable devices in electronic patient records.
Finalized plans for the EU UDI system are still likely some months away; it appears, though, that major market regulators will stay on the same page when it comes to implementing such systems.