Exceptional Use Authorisation

AI Summary

The Medicines and Healthcare products Regulatory Agency (MHRA) provides guidance for Exceptional Use Authorisations (EUA), which allow medical devices lacking standard UKCA or CE certification to be used for public health protection. This process applies to Great Britain under the UK Medical Devices Regulations 2002 and to Northern Ireland under the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The primary issue addressed is the lack of valid certification marks, which is only permitted when there is an immediate clinical need or a supply shortage of alternative devices, specifically within government-funded settings like the NHS. To qualify, manufacturers or their UK representatives must provide evidence of the device's safety, ISO certification, and clinical performance. Required actions for authorized manufacturers include monthly reporting to the MHRA regarding supply volumes, patient complaints, and adverse events. Additionally, manufacturers must demonstrate a clear timeline and plan for achieving full regulatory conformity. EUAs are temporary measures and are not intended for private commercial distribution. The MHRA assesses applications through a technical and clinical review process, and all granted authorizations are published publicly on the GOV.UK website.