TIC Council shares today with the European Commission its recommendations to improve the efficiency and speed of implementation of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR), which have already entered into force and are applicable from May 2021 and May 2022 respectively.
These two new EU Regulations aim to improve patient safety by strengthening qualification requirements for medical infrastructures, devices, products, as well as by tightening market surveillance requirements. In line with the TIC sector’s mission to support the design of policies that improve health and safety while promoting innovation and facilitating trade, the objectives of these new Regulations are fully supported by TIC Council.
In doing so, and by publishing this set of suggestions and guidelines, TIC Council aims to ensure the continued availability of safe and effective medical devices/IVDs on the European market and to guarantee the safety of European patients.
The recommendations can be found below.