The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a four-week consultation which will support improved safety for certain high-risk IVD devices.
Accurate performance and trust in the quality of in vitro diagnostic (IVD) products is crucial to healthcare professionals considering their use in treating patients.
The new policy the MHRA is 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.
The MHRA says it is 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.It follows from the publication in January this year of a regulatory ‘roadmap’, pointing the way ahead for new measures to support safe access to medical technology including AI and diagnostics.
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.”