The MHRA has updated it's guidance covering the regulation of medical devices. As the implementation of the European Medical Device Regulation (MDR) has been delayed by a year (now 26th May 2021) due to the COVID-19 pandemic, the UK's transition period with the EU will have ended and therefore MDR will not become UK law.
A new legislation covering UK medical devices will be consulted on to strengthen patient safety. The MHRA states
"We have the opportunity to develop a robust, world-leading regulatory regime for medical devices that prioritises patient safety. We will take into consideration international standards and global harmonisation in the development of our future system.
We will engage with stakeholders within the life sciences and healthcare sectors on this proposed regime this autumn. As part of these discussions, we will identify and prioritise elements of international practice that promote public health and patient safety. This will be followed by a formal public consultation with the aim of delivering an attractive world-class regulatory system."
The IMPT will continue to update members as further information is available.
The full text can be accessed here.
