UK – MHRA increases UK assessment capacity for in-vitro diagnostic devices

The Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that UL International UK Ltd is now designated to assess most in-vitro diagnostic (IVD) devices, increasing the UK’s capacity to process conformity assessments and ensure safe and effective IVDs reach the UK public

UL International UK Limited have had their current designation as an approved body extended to include almost all Part IV In-vitro Diagnostics Medical Devices, 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 certification. 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…