Specific areas of development

Borderline products

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.

Reprocessing of medical devices

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.

• Outcome of the first public consultation on the reprocessing of medical devices(133 KB)
• 5 December 2008 workshop on reprocessing of Medical Devices
  • Summary report(44 KB)
  • Presentations
• Scientific Committee on Emerging and Newly Identified Health Risks (SCENHIR) opinion on the safety of reprocessed single-use devices
• Report on the issue of the reprocessing of medical devices in the European Union, inaccordance with Article 12a of Directive 93/42/EEC(80 KB)  Deutsch (de) français (fr)

Counterfeiting

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.

Traceability

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).