26/27 May 2021
The labelling of medical devices is an important issue for the EU Commission as well as it contributes decisively to the traceability and therefore also to patient safety. Moreover, it facilitates vigilance and transparency. Since there are no specific provisions as regards the traceability of medical devices in the European regulatory framework for medical devices, the EU Commission has now published "Recommendations on a common framework for a system of unique product marking for medical devices". In these recommendations the Commission specifically refers to the currently internationally discussed Unique Device Identifier (UDI). With regard to these UDI mechanisms it sees the danger, though, that they could develop differently on a national and / or regional level.
Read more in the recommendations themselves.