LONDON–On January 1, 2021, new regulations by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK (England, Scotland, and Wales) will require medical devices of all classes to be registered with the agency. These regulations may impact the number of approved medical devices in the future.
Manufacturers will be given a grace period of four to 12 months to comply with the new registration process, depending on the risk of the device, Higher-risk devices require an earlier registration. Manufacturers based outside the UK will need to appoint a UK Responsible Person to register devices with the MHRA in line with the grace periods.
In the UK , all medical devices will require a UKCA (UK Conformity Assessed) mark by July 1, 2023. CE marks issued by EU notified bodies will remain valid until this period. However, UKCA marking alone will not be recognized in the EU.
The MHRA will gain the power to designate UK approved bodies by assessing if products meet the UKCA mark requirements. Existing UK notified bodies currently designated under EU directives will automatically become UK approved bodies on January 1, 2021, without having to undergo new designation processes.
The new regulations could potentially impact the number of approved medical devices in the next few years. According to GlobalData’s pipeline products database, there are more than 17,000 active medical devices currently in the pipeline, with approximately 42 percent of the devices in the early stages of development.
The high proportion of products being developed in the EU and UK indicates that a vast majority of devices will be caught in transitioning approval processes, which may lead to a temporary decline in the volume of approved devices.