The announcement of three new UK Approved Bodies to certify medical devices is a positive step, but according to Elaine Gemmell, Head of Regulatory Affairs at InnoScot Health, more resources are still needed. While having seven approved bodies in place will enable quicker certification of medical devices, there are still clear resource issues that need to be addressed. TÜV SÜD, Intertek, and TÜV Rheinland UK have joined the current UK Approved Bodies, doubling the capacity for certifying safe and effective medical devices in the UK. Gemmell believes that these additional bodies are much needed to bolster UKCA certification capacity following Brexit, but it is not yet enough to support manufacturers trying to bring their products to the UK.
Gemmell highlights that while the announcement of the three new approved bodies is a positive development, it deflects from the bigger issues surrounding new medical devices legislation, the application timeline, requirements, and the continued recognition of CE marks. She emphasizes that more resources are needed to ensure a smooth transition and to support manufacturers navigating the changing regulatory landscape. Gemmell also mentions that CE marking is still allowed for device submissions to the British market, and with a grace period for acceptance of CE marked medical devices, it becomes clear that the focus on bolstering UKCA certification capabilities needs to intensify.
In summary, the addition of three new UK Approved Bodies to certify medical devices is a step in the right direction, but more resources are needed to address ongoing resource issues and support manufacturers in bringing their products to the UK. These bodies will bolster UKCA certification capacity following Brexit, but they are not yet sufficient to meet the demands of the transition from CE marks. The announcement also deflects from the bigger issues surrounding new medical devices legislation, application timelines, requirements, and continued recognition of CE marks. Therefore, it is crucial to allocate more resources to ensure a smooth transition and support manufacturers in navigating the changing regulatory landscape.
