The announcement of three new UK Approved Bodies to certify medical devices is a positive development, but according to Elaine Gemmell, Head of Regulatory Affairs at InnoScot Health, more resources are needed. Gemmell states that while the addition of these bodies will enable quicker certification of medical devices, there are still 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, significantly increasing the capacity for certification in the country. However, Gemmell argues that these additions alone are not enough to support manufacturers trying to bring their products to the UK.
Gemmell emphasizes the importance of bolstering UKCA (UK Conformity Assessed) certification capabilities ahead of the transition deadline from the CE mark. While the three new Approved Bodies are a step in the right direction, Gemmell believes that more needs to be done to support manufacturers. She also points out that the announcement of these bodies deflects attention from other pressing issues, such as the ongoing uncertainty surrounding new medical devices legislation and the continued recognition of CE marks.
In conclusion, although the inclusion of three new UK Approved Bodies for medical device certification is a positive move, Elaine Gemmell argues that greater resources are still necessary. While these additions will increase certification capacity, Gemmell believes that it is not sufficient to fully support manufacturers bringing their products to the UK. She also highlights the need for more focus on bolstering UKCA certification capabilities and addressing the uncertainties surrounding new medical devices legislation and the recognition of CE marks.