In addition to the capacity already provided for these kinds of products by BSI Assurance UK Ltd. and SGS United Kingdom Ltd., UL International UK Limited has had their current designation as an approved body extended to include almost all Part IV In-vitro Diagnostics Medical Devices.
For UKCA certification, manufacturers of self-test IVDs and those for specific high-risk tests must apply to a UK approved body. After they have been certified, products can only be sold in England, Wales, and Scotland.
The MHRA’s in-depth assessment process is meant to make sure that any organizations that want to certify medical devices are stable, capable of conducting impartial and objective assessments, have the resources to conduct assessments, and the processes and ongoing certification necessary to meet the relevant regulatory requirements.
The UK MHRA’s chief healthcare quality and access officer, Dr. Laura Squire OBE, stated that the organization’s mission is to ensure that patients in the UK have access to high-quality medical products that can safeguard their health. This can only be accomplished by expanding the system’s ability to evaluate In-Vitro Diagnostic devices.
Dr. Laura Squire went on to say that the approved bodies are essential to the supply of IVDs and medical devices, and that we will continue to collaborate closely with applicants throughout the upcoming year to free up even more capacity.