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Challenges in Battling Falsified Medical Devices and Calls for Awareness

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The Committee of Experts on Minimizing Public Health Risks associated with counterfeit medical products and related offenses (CD-P-PH/CMED) released a report shedding light on authorities’ perception and management of falsified medical devices. The detection of falsified medical devices in Council of Europe member states remains an issue, as highlighted in a recent survey, despite limited investigations and prosecutions into these matters.

This survey was prompted by the lack of available data on this serious global concern. Understanding the current landscape of falsified medical devices proves challenging due to insufficient information, making it difficult to evaluate the extent of the problem.

Challenges in Combating Falsified Medical Devices Revealed

The broad spectrum of medical devices, encompassing over 500,000 products, presents an intricate domain with continuous advancements in technology and product variations. Establishing robust legal frameworks and surveillance systems in this field remains an ongoing effort due to its complexity and rapid evolution. Moreover, the implementation of the latest EU regulations governing medical devices (2017/745 and 2017/746) is still in its nascent stages. Consequently, there is a dearth of information regarding the effectiveness of these regulations in combating falsified medical device.

Findings from the survey affirmed the existence of falsified medical device; however, they revealed a stark reality: there are limited investigations, and even fewer prosecutions are pursued. While seven countries acknowledged awareness of criminal investigations related to falsified medical devices, only five reported knowledge of actual prosecutions.

Medical Devices

Obstacles to Investigating Falsified Medical Devices

Several challenges were identified as hindrances to conducting investigations. These included insufficient experience in handling such cases, inadequate resources, and low prioritization of medical device cases within law enforcement activities. Furthermore, the survey exposed significant gaps in data collection and information sharing regarding suspected falsified medical devices. This lack of comprehensive data exchange contributes to a fundamental issue: a widespread lack of understanding about the nature of medical device, leading to limited awareness about the problem of falsification across various levels.

The report concluded that improving the application of existing legislation and enhancing enforcement mechanisms could yield positive outcomes beyond investigations and prosecutions. It emphasized the potential benefits of better enforcement, including improved information exchange, heightened awareness among authorities and stakeholders, and increased understanding of the issue at hand.


Resource: European Pharmaceutical Review, December 4, 2023

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