This Regulation lays down rules concerning the placing/making available on the market or putting into service of in vitro diagnostic medical devices for human use conducted in the EU. This Regulation also applies to performance studies concerning such in vitro diagnostic medical devices and accessories conducted in the Union, and any device which, when placed on the market or put into service, incorporates, as an integral part, a medical device shall be governed by this Regulation.
Therefore, this Regulation aims to ensure the smooth functioning of the internal market as regards in vitro diagnostic medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small and medium-sized enterprises that are active in this sector. At the same time, this Regulation sets high standards of quality and safety for in vitro diagnostic medical devices in order to meet common safety concerns as regards such products. Both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other.
Furthermore, this Regulation harmonises the rules for the placing on the market and putting into service of in vitro diagnostic medical devices and their accessories on the Union market thus allowing them to benefit from the principle of free movement of goods, and sets high standards of quality and safety for in vitrodiagnostic medical devices by ensuring, among other things, that data generated in performance studies are reliable and robust and that the safety of subjects participating in performance studies is protected.
To ensure a high level of safety and performance, demonstration of compliance with the general safety and performance requirements laid down in this Regulation should be based on clinical evidence. It is necessary to clarify the requirements for the demonstration of the clinical evidence, that is based on data on scientific validity, and the analytical performance and clinical performance of the device. To allow for a structured and transparent process, generating reliable and robust data, sourcing and assessment of available scientific information and data generated in performance studies should be based on a performance evaluation plan.
