The announcement of three new UK Approved Bodies to certify medical devices is a positive step but more resources are still needed, insists a regulatory specialist

Head of Regulatory Affairs at InnoScot Health, Elaine Gemmell, believes that the Medicines and Healthcare products Regulatory Agency (MHRA) moving to add the new bodies to its roster is to be welcomed.

However, she also believes that “whilst now having seven approved bodies in place is a further step in the right direction which will enable quicker certification of medical devices for healthcare professionals and the public, there are still clear resource issues that need to be addressed.”

TÜV SÜD, Intertek, and TÜV Rheinland UK join the four current UK Approved Bodies, almost doubling current capacity for the certification of safe and effective medical devices in the UK.

TÜV SÜD and Intertek will assess and certify general medical devices in accordance with Part II of the UK Medical Devices Regulations 2002.

TÜV Rheinland UK will do the same but will further assess and certify in-vitro diagnostics in accordance with Part IV.

The trio now sit alongside existing bodies BSI Assurance UK, DEKRA Certification UK, SGS United Kingdom and UL International in conducting conformity assessments.

Elaine said: “There’s no doubt that these additional Approved Bodies are much needed and will bolster UKCA certification capacity following Britain’s legislative cut-off from Europe during Brexit. It is also positive that EU Notified Bodies TÜV SÜD, Intertek, and TÜV Rheinland UK are being designated as UK Approved Bodies, demonstrating confidence in our system.

“However, despite an extension to acceptance of CE-marked devices on to the British market, three new Approved Bodies is not yet enough to bolster UKCA certification capabilities ahead of the implementation of the future UK regulatory framework deadline, and the focus on that will only continue to intensify.

“It is simply not sufficient to support manufacturers who are trying to bring their products to the UK.”

Last month it was announced that a grace period for the acceptance of CE marked medical devices in Great Britain has been extended until 30 June 2028 for general medical devices compliant with the EU medical devices directive. For general medical devices, including custom-made devices, compliant with the EU medical devices regulation, the deadline will be 30 June 2030.

Elaine – recently awarded the title of Honorary Professor in the School of Engineering and Physical Sciences at Heriot-Watt University – continued: “The announcement of three new approved bodies also deflects from the far bigger issues of the ongoing uncertainty around the publication of new medical devices legislation, when it will apply, what will be required, and the continued recognition of CE marks.”

InnoScot Health offers a skilled team of regulatory experts, dispensing advice and support to healthcare innovators across Scotland, while facilitating and underlining the country’s reputation as a centre of excellence for medical device innovation. The organisation also operates an ISO 13485:2016 quality management system harmonised to the Medical Device Directive.

With more than 20 years’ experience in medical device development, Elaine Gemmell is a certified ISO 13485/ISO 9001 Lead Auditor and has experience of regulatory approval and CE marking for medical devices.