Regulations (EU) 2017/745 and (EU) 2017/746 of the European Parliament and of the Council establish a regulatory framework to ensure the smooth functioning of the internal market as regards medical devices and in vitro diagnostic medical devices, taking as a base a high level of protection of health for patients and users. At the same time, Regulations (EU) 2017/745 and (EU) 2017/746 set high standards of quality and safety for medical devices and in vitro diagnostic medical devices in order to meet common safety concerns as regards such devices. Furthermore, both Regulations significantly reinforce key elements of the previous regulatory framework set out in Council Directives 90/385/EEC and 93/42/EEC and in Directive 98/79/EC of the European Parliament and of the Council, such as the supervision of notified bodies, risk classification, conformity assessment procedures, clinical evidence requirements, vigilance and market surveillance, and require the setting up of the European database on medical devices (Eudamed) to enable transparency and traceability in respect of medical devices and in vitro diagnostic medical devices.
Text as published in the Official Journal, reproduced verbatim (including any typographical quirks of the source). For the authentic version, see EUR-Lex.
