(Version 1.1 published 7th July 2020)
On 26th May 2017, the Medical Devices Regulation (MDR 2017/745) was published, with the aim of replacing the current Medical Devices Directive (MDD 93/43/EC). Following a transition period of 3 years, this regulation will be applied in full from 26th May 2020.
In this position statement, the BOA recognises the ongoing necessity for the increased rigour in pre-market evaluation, certification and post-market surveillance of new devices, and welcomes the reduction in risk to patients that the MDR should bring. We also highlight potential problems with the implementation of the new regulation, and make recommendations for the handling of some of the issues that could arise.