Control over the circulation of falsified MD — the experience of European countries

The common space of the European Union allows the member states to take a more comprehensive and global approach to solving many issues, including the problem of circulation of falsified medical devices. As a result of the implementation of the global approach, regulations are being created to strengthen international cooperation, including with countries outside the EU (for example, the Convention Medicrime), as well as containing measures to prevent the distribution of falsified products. However, despite the unification of European countries into a single economic space, many questions regarding the circulation of falsified products (e.g. liability for the circulation of falsified MD) is regulated at the country level.

As already noted, the cooperation of the EU countries and some others in relation to countering the circulation of falsified MD is formalized in the Medcrime Convention (there is a separate article about it).

  • International regulations.

In addition to the Convention, there are a number of international normative documents regarding MD applicable in the EU:

  • REGULATION (EU) 2017/745, which applies to MD with the exception of MD for in vitro diagnostics. This document provides a definition of falsified MD, provides some measures to combat falsification (for example, the introduction of unique device identifier (UDI), instructions for importers/ distributors upon detection of a falsified MD (it is necessary to notify the manufacturer and its authorized representative, as well as the competent authority (CA) of the Member State), as well as instructions for competent authorities (if necessary, the CA can confiscate, destroy and disrupt falsified MD).
  • REGULATION (EU) 2017/746 (effective May 22, 2022), which applies to MD for in vitro diagnostics and contains information similar to Regulation 2017/745.
  • Local regulations.

If we talk about liability for the circulation of falsified MD, this aspect is regulated at the national level. For example, Hungary provides for imprisonment for periods ranging from one to eight years depending on the circumstances, while in Poland the liability for circulation of falsified medical devices is not clearly stated. In Poland the circulation of falsification may fall under more general articles (threat to life and health of the population – imprisonment for a period of 6 months to 8 years; falsification of labeling, production date, expiration date – imprisonment up to 3 years).

In Serbia, which is not a member of the European Union, according to the Criminal Code, liability for the circulation of MD capable of causing harm to health, is provided in the form of imprisonment for a period of 6 months to 5 years along with fine.