Intertek receives UK Approved Body Designation under Part II of the UK Medical Devices Regulations 2002
24 Aug 2023
Brentwood, UK: Intertek, a leading total quality assurance provider to industries worldwide, is pleased to announce 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.
IMNB UK Ltd is one of the first organisations to become a UK Approved Body to certify medical devices since Brexit. 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:
https://www.gov.uk/government/publications/medical-devices-uk-approved-bodies.
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.”
Please visit our webpage for more information about UK Market access – Medical Device UKCA certification: https://www.intertek.com/assurance/ukca/.
Existing clients are encouraged to apply for UKCA certification via their current Project Manager or, directly, using IMNB@intertek.com.
New clients who wish to apply or require further information can also contact us at IMNB@intertek.com.
For Media Information
Please contact:
Lauren Whittemore
VP Global Marketing & Group Digital Experience
T: +1 978 319 8904
E: lauren.whittemore@intertek.com
For Technical Information
Please contact:
Sharmila Gardner
E: sharmila.gardner@intertek.com
About Intertek
Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices and over 42,000 people in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification solutions for our customers’ operations and supply chains. Intertek Total Quality Assurance expertise, delivered consistently with precision, pace and passion, enabling our customers to power ahead safely.