This Practice Note introduces the regime for regulation of the manufacture and sale of medical devices in the EU under Directive 93/42/EEC on medical devices, Directive 90/385/EEC on active implantable medical devices and Directive 98/79/EC on in vitro diagnostic medical devices. It explains how devices are classified, assessed (by completion of a conformity assessment) and CE marked. This Practice Note also considers the advertising and promotion or medical devices, counterfeit medical devices, 3D printing and mobile health.
This Practice Note explains the concept of regulatory data protection (RDP), also known as ‘data exclusivity’, provides guidance on how RDP works in practice and the impact it has on the entry into the market of generic and biosimilar medicinal products.
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