Back Falsification of medical devices – Results of European survey

EDQM Strasbourg, France 28/11/2023
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Falsification of medical devices – Results of European survey

The falsification of medical devices is a serious international matter of concern, but little data is available, making it difficult to assess the current state of affairs. To help bridge this gap, the Committee of Experts on Minimising Public Health Risks Posed by Falsification of Medical Products and Similar Crimes (CD-P-PH/CMED) carried out a survey on how authorities in Council of Europe member states perceive and address the issue of falsification of medical devices. The results are now available in a report providing a selection of questions, answers and comments, along with the key findings.

In summary, the survey responses firstly confirmed the existence of the issue of falsified medical devices. However, few investigations (at criminal level, in particular) are instigated, and even fewer prosecutions. Data collection is practically inexistent, and hence very little data is available. To date, exchanges of information on this topic have been rare.

Medical devices – products or equipment intended for a medical purpose – form a vast category, comprising over 500 000 products available. The field is currently seeing major developments in terms of new technologies and new types of products. Due to the complexity of the area, work to establish effective legal frameworks and monitoring systems is still ongoing. Furthermore, implementation of the latest EU regulations applicable to medical devices (2017/745 and 2017/746) is still in its early stages and thus little information exists on their impact in addressing the falsification of medical devices.

These results must be considered in the proper context: the regulatory framework for medical devices, compared to that of medicines, is still relatively new. This is also reflected in the systems and processes in place to handle irregularities and the resources available to deal with them.

The survey report is available online on the CD-P-PH/CMED work programme web page.

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