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.
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.”
Find out more
Notes to editors
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An approved body is an organisation that has been designated by the MHRA to assess whether manufacturers and their medical devices meet the requirements set out in the UK Medical Devices Regulations 2002.
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Types of device that UL Intl Ltd are not designated to assess are: IVD 0204 - Variant Creutzfeldt-Jakob disease (vCJD); IVD 0304 - Hereditary disease: phenylketonuria; IVD 0306 - HLA tissue groups: DR, A, B; IVD 0402 - Haematology
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Guidance for the types of IVD’s that require approval can be found in section 3.5 of this document:
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Between September and November 2021, the MHRA consulted on proposed changes to the regulatory framework for medical devices in the United Kingdom (UK). The proposals, alongside the consultation response and Government response have been published.
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The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
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The MHRA is an executive agency of the Department of Health and Social Care.