The announcement of three new UK Approved Bodies to certify medical devices is seen as a positive step, but according to Elaine Gemmell, Head of Regulatory Affairs at InnoScot Health, more resources are still needed. While the addition of these bodies will enable quicker certification of medical devices, there are still clear resource issues that need to be addressed. The three new bodies, TÜV SÜD, Intertek, and TÜV Rheinland UK, will join the four existing UK Approved Bodies, expanding the capacity for certification in the UK.
Gemmell believes that these additional Approved Bodies are necessary to bolster the UKCA certification capacity following Brexit and the legislative cut-off from Europe. However, she emphasizes that three new bodies are not enough to meet the demand for UKCA certification capabilities ahead of the deadline for the transition from CE mark. Gemmell also raises concerns about the ongoing uncertainty around new medical devices legislation and the recognition of CE marks. Overall, she argues that while the addition of these new bodies is a step in the right direction, more resources and clarity are needed to support manufacturers trying to bring their products to the UK market.
In summary, the announcement of three new UK Approved Bodies to certify medical devices is regarded positively, but Elaine Gemmell highlights the need for additional resources. While the new bodies will enhance the certification process, there are still resource issues that must be addressed. The inclusion of TÜV SÜD, Intertek, and TÜV Rheinland UK expands the capacity for certification in the UK, but three new bodies are not sufficient to meet the demand for UKCA certification. Gemmell also expresses concerns about the ongoing uncertainty surrounding new medical devices legislation and the recognition of CE marks.