UDI in the European Union
The European Commission has published the Official Journal document "2013/172/EU: Commission Recommendation of 5 April 2013 on a common framework for a unique device identification system of medical devices in the Union Text with EEA relevance."
The introduction states:
Traceability is currently not regulated by the medical device directives while it is addressed in some cases at national and/or regional level...
The best way to ensure effective traceability of medical devices in the Union is to develop a UDI system harmonised at European level. The ongoing revision process of the current Directives on medical devices should empower the Commission to adopt detailed traceability requirements.
The commission's recommendations outline the advantages of unique device identification (UDI) and a common approach to traceability. "Harmonisation of the medical device regulatory framework is being carried out under the auspice of the International Medical Device Regulators Forum," which includes US representatives.
The document gives no specific indication of co-operation with the FDA, but it acknowledges in the prologue, "Significant efforts are being made at international level towards a globally harmonised approach on traceability and to establish a globally accepted unique device identification (UDI) system for medical devices."
The recommendations also state:
Once the future European databank on medical devices (Eudamed) is established, information related to device identifier (static information) will be centralised at European level via a European UDI electronic system which will be part of the future Eudamed.
I find this reference to storing data in the Eudamed databank surprising, because the EU Commission website states:
Eudamed is a secure web-based portal acting as a central repository for information exchange between national competent authorities and the Commission and is not publicly accessible [emphasis in original].
The recommendations define the conditions to be fulfilled by economic operators, including manufacturers, importers, authorised representatives, distributors, health institutions, and professional users. In summary, these economic operators should "should store through the distribution chain information related to both the device identifier (static information) and the production identifier (dynamic information)." Only static information should be passed to the national UDI databases.
Recommendations are made for the content of UDI national databases; an annex lists 21 database elements, and "Member States who intend to establish a UDI system for medical devices are invited to build it on national UDI databases."
I suggest that anyone involved in the creation of medical device labels should take a few minutes to read this EU document. Those with considerable stamina may also wish to compare it with the FDA UDI System proposed rule tome.
With new proposals for a free trade area between the United States and the European Union, can we perhaps hope for a common approach to UDI and a shared database?
Rolande Hall, FIMMM Pkg Prof