Intertek becomes latest UK medical device approved body

Intertek, a quality assurance provider to industries worldwide, has announced that Intertek Medical Notified Body UK Ltd (IMNB UK Ltd) has been designated against the UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) by the Medicines and Healthcare products Regulatory Agency (MHRA).

With its designation, Intertek is permitted to conduct UKCA conformity assessments and issue UKCA certificates for a range of active non-implantable and non-active medical devices, supporting clients to bring their products to market in Great Britain, as the UKCA marking will replace CE marking.

For more information on the designated scope / types of medical devices for which the IMNB UK Ltd (AB number 8532) is permitted to issue UKCA certification, refer to the government page linked here.

Dr Sharmila Gardner, head of the UK Approved Body said: “This designation reflects the exceptional dedication of our staff, their expertise, and the maturity of our quality management system. We are delighted to be able to offer our existing and new medical device clients around the world a portfolio of services that now assures continued market access to the UK through UKCA and UKAS ISO 13485 certification.”

IMNB UK Ltd is one of the first organisations to become a UK Approved Body to certify medical devices since Brexit, along with TUV SUD who became a notified body earlier this month.