Medical Device Compliance with Specialist Information

The role of medical devices in healthcare is essential. The diversity and innovativeness of this sector contribute significantly to enhance the quality and efficacy of healthcare. Covering a wide range of products, from simple bandages to the most sophisticated life-supporting products, the medical devices sector plays a crucial role in the diagnosis, prevention, monitoring, and treatment of diseases and the improvement of the quality of life of people suffering from disabilities.

Science evolves quickly in the areas of medical devices and in vitro diagnostic medical devices. In an internal market of various participating countries that are subject to constant technological and scientific progress, important differences in interpreting and applying the rules have emerged, thus undermining the legislation's main objectives — the safety of devices and their free circulation within the internal market. Moreover, there are regulatory gaps or uncertainties with regard to certain products. The regulatory system has also suffered from a lack of transparency and shortcomings in its implementation, in particular in the fields of market surveillance, vigilance and the functioning of notified bodies. In addition, recent serious incidents involving medical implants (e.g. breast implants, metalon-metal hip replacements) have put patient safety at risk and have, without doubt, badly damaged the confidence of patients, consumers and healthcare professionals in the safety of the devices on which they may rely every day. These incidents have revealed further shortcomings of the current legislation, especially with regard to post-market controls.

Safe, effective and innovative medical devices and in vitro diagnostic medical devices for the benefit of patients, consumers and healthcare professionals

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