IVD devices are used to examine samples taken from the human body and to diagnose and monitor health conditions. For example, devices can determine blood glucose levels and can identify infectious diseases. Accurate performance and trust in the quality of these products are crucial to healthcare professionals considering their use in treating patients.
The new policy we are consulting on would require manufacturers to comply with additional measures for certain high risk IVDs, such as blood tests used to identify blood type before transfusions or tests which identify life-threatening diseases, introducing harmonised requirements for these products.
We are also seeking views on the removal of the Coronavirus Test Device Approval (CTDA) process to avoid duplication of regulatory requirements for COVID-19 tests against the Common Specification requirements.
The MHRA intends to incorporate updates to IVD common specifications within a draft Statutory Instrument as part of the future core medical device regulations to be published later in 2024. The updated regulations will then come into force in 2025.
Dr Laura Squire, MedTech Regulatory Reform Lead and Chief Healthcare Quality and Access Officer, MHRA said:
We look forward to feedback on our consultation on common specification of IVDs, as we look to strengthen safety requirements around certain classes of crucial diagnostic devices.
Notes
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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.
