Intertek has received official designation as a UK Approved Body, enabling the organization to conduct UKCA conformity assessments and issue UKCA certificates for a variety of active non-implantable and non-active medical devices. This designation supports manufacturers in bringing their products to the market in Great Britain, where the UKCA marking is set to replace the CE marking.
For a comprehensive overview of the specific types of medical devices falling under the scope of IMNB UK Ltd’s (AB number 8532) UKCA certification authorization, please refer to the linked government page.
Dr. Sharmila Gardner, the Head of the UK Approved Body, stated, “This designation is a testament to the unwavering commitment of our team, their profound expertise, and the maturity of our quality management system. We are thrilled to extend our array of services to both existing and new clients in the global medical device sector. This expansion ensures continued market access to the UK through UKCA and UKAS ISO 13485 certification.”
IMNB UK Ltd joins a select group as one of the initial organizations to attain UK Approved Body status for certifying medical devices post-Brexit. This achievement is in conjunction with TUV SUD, which recently obtained notified body status earlier this month.
