Internal Market, Industry, Entrepreneurship and SMEs

Specific areas of development

Specific areas of development

Borderline products

So-called borderline products are those for which it’s not clear whether they fall under the medical devices legislation or another piece of legislation.

These cases are of great concern to EU countries, the European Commission and other stakeholders since they can lead to different interpretations within the EU, and as a consequence, may put public health at risk and distort the single market.

To ensure a uniform approach, the Commission tries to facilitate a dialogue between regulators and industry, where diverse interpretations exist.

Key documents on borderline and classification

Medical devices expert group on borderline and classification

Other useful guidance

Reprocessing of medical devices

As set out in Directive 93/42/EEC, the Commission has analysed the issue of the reprocessing of single-use medical devices within the EU.

More on reprocessing of medical devices


Counterfeiting of health products is a serious and growing concern, since this practice endangers patients’ safety and health. Both complete medical devices and separate device parts have been counterfeited. To fight against this activity steps are taken at EU, regional and international level to ensure that only authentic products are delivered to European citizens.

Consequences of counterfeiting

  • Health and safety: Counterfeit medical devices can have adverse effects, including potentially lethal consequences, as they are often non-sterile, of poor quality, contain inappropriate materials and be of questionable effectiveness. One of the most severe implications of counterfeit medical devices is clearly the adverse health implications for consumers
  • Economic: Counterfeit medical devices also distort competition, damage legitimate producers’ interests and their brand names, undermine employment and reduce tax income. Manufacturers are adversely affected by loss of sale and loss of reputation when counterfeit parts fail that have been branded with their company’s trademark

The Commission issued a study on distribution channels (106 kB) dealing with counterfeit issues. The goal is to assist and encourage the development and implementation of government policies and regulations that combat and dissuade the production and trade of counterfeit medical devices.

It is essential that mechanisms to detect and prevent counterfeit medical devices are provided for throughout the European Union.

Traceability – unique device identifier

The unique device identification (UDI) is a unique numeric or alphanumeric code pertaining to a medical device, in 2 parts

  • a device identifier
  • a production identifier

These provide access to useful and relevant information regarding the device. Due to the UDI’s specificity

  • it makes traceability of devices more efficient
  • allows easier recall of devices
  • combats counterfeiting
  • improves patient safety

The UDI will not be a substitute for, but an addition to the existing labelling requirements for medical devices.

The EU, as Chair of the IMDRF (international medical device regulators forum) working group on UDI, has strongly contributed to the preparation of the international guidance on a unique device identification (324 kB) (UDI) -system for medical devices, which was adopted in December 2013.

The Commission issued a recommendation in April 2013 on a common framework for a unique device identification system of medical devices in the EU. This is to provide the basis of the EU's future identification and traceability infrastructure, in line with the latest developments at international level.