Medical Devices Regulation from 2020
On 26 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 three years, this regulation will be applied in full from 26 May 2020.
The BOA has recently published its position statement on the MDR. They welcome the drive to improve the rigour and regulation of novel devices and procedures for the benefit of patients. However, the BOA raises some particular concerns with regard to legacy devices, regulation of different types of device, value of registry data in evaluating devices and long term monitoring. The BOA’s position statement is available here.
NHS England waiting times for elective surgery
NHS England waiting times for September 2019 were published and showed the worst performance this decade for several metrics. It is now a full five years since the waiting time targets were last met for the Trauma & Orthopaedic specialty, and over 90,000 people had been waiting over eighteen weeks for treatment.
The BOA published a statement highlighting their concerns at the growing problem, which can be found on the BOA website, here.