Booklet: Are you ready for EU MDR 2017/745-746?

This booklet from PQE Group is your opportunity to learn how the new EU directives – EU MDR 2017/745-746 – affect your company. Read on to find out what preparations you can make to ensure that your products comply.

On 26 September 2012 two legislative proposals addressing MD and In Vitro were proposed at the European Commission, followed by extensive expert consultations resulting in an agreement stipulated on 5 October 2015 among Member States’ health ministers on the general approach to the medical devices package, leading to the issuing of the new EU-MDR regulations in 2017.

Issued officially on 25 May 2017, the EU MDR 2017/745 introduced new regulations for the medical devices sector, to establish a modern EU legislative framework and ensure better protection of public health and patient safety. Regulation 745/2017 (MDR) concerning medical devices, repealed Directives 90/385 / EEC and 93/42 / EEC, and Regulation 746/2017 (IVDR) related to in-vitro diagnostic devices. The new regulations will apply after a transitional period: on 26 May 2020 for medical devices, and on 26 May 2022 for in-vitro diagnostics.