The so-called borderline products are those where it is not clear whether they fall under one or another piece of legislation.
These cases are of great concern to Member States, the Commission and other stakeholders since they can lead to different interpretations within the Community, and as a consequence, may put public health at risk and distort the Single market.
Therefore, in order to ensure a uniform approach, the Commission services try to facilitate a dialogue among regulators and industry where diverse interpretations exist.
With the same aim of ensuring a high level of health protection, the Commission services are currently analysing the issue of the reprocessing of medical devices in the Community.
Counterfeiting of health products is a serious and growing concern since this practice endangers patients’ safety or health. To fight against this phenomenon, activities are undertaken at the Community, Regional and International levels in order to ensure that only authentic products are delivered to the European citizens.
In order to improve the global traceability of devices and patient safety, the EU is actively contributing to the development of a global Unique Device Identification for medical devices (UDI).