Traceability is currently not regulated by MDD 93/42/EEC, nor by IVDD 98/79/EC or AIMD 90/385/EEC. EU Commission published the COMMISSION RECOMMENDATION of 5 April 2013 on a common framework for a unique device identification system of medical devices in the Union.
The Recommendation mainly discusses the Unique Device Identification (UDI) system for the better traceability of medical devices, active implantable medical devices and in-vitro medical devices.
The UDI should comprise two parts, a device identifier and a production identifier, and the system should be implemented gradually, starting from Class III.
Not only manufacturers should keep a close watch to the development and implementation of the UDI system, but importers, EU Authorized Representatives as well as distributors should also be involved.
The implementation date of the UDI System is not clear so far, but this Recommendation is obviously a step forwarder towards the target.
A copy of the recommendation can be downloaded here.
