UL International UK Limited have had their current designation as an approved body1 extended to include almost all Part IV In-vitro Diagnostics Medical Devices2, adding to the capacity already provided for these types of products by BSI Assurance UK Ltd and SGS United Kingdom Ltd.
Manufacturers of self-test IVDs, and those for specific high-risk tests must apply to a UK approved body for UKCA certification3. Products can only be placed on the market in England, Wales and Scotland after they have achieved certification.
The MHRA's detailed assessment process is designed to ensure that any organisations that wish to certify medical devices are stable, able to undertake impartial and objective assessments, have an appropriate quality management system in place to support them, the resources to undertake the assessments, and the processes and ongoing certification in place to meet the relevant regulatory requirements.
Dr Laura Squire OBE, Chief Healthcare Quality and Access Officer at the MHRA, said:
Our mission is to ensure patients across the UK have access to the high-quality medical products they need to protect their health. Increasing capacity within the system to assess In-Vitro Diagnostic devices is critical to achieving this.
Approved Bodies play a vital role in the supply of medical devices and IVDs, and we will continue to work closely with applicants over the coming year to unlock even more capacity.
