Exceptional use of non-UKCA marked medical devices

AI Summary

The UK Medicines and Healthcare products Regulatory Agency (MHRA) provides guidance for medical device manufacturers regarding the exceptional use of devices that do not carry a UKCA mark. Governed by the UK Medical Devices Regulations 2002 (UK MDR 2002), specifically Regulations 12(5), 26, and 39(2), this provision allows for the supply of non-compliant devices when no legitimate alternative is available and patient health is at risk. To qualify, manufacturers must demonstrate that the device is intended for a single named patient, has the full support of the treating clinician, and will significantly reduce mortality or morbidity compared to compliant options. The application process requires both the manufacturer and the clinician to submit joint documentation to the MHRA. While the agency generally reviews applications on a case-by-case basis within a 48-hour window, exceptions may be made for emergency stockpiling in rare instances. This regulatory framework ensures that critical, non-standard medical technologies can be accessed legally in life-threatening situations where standard UKCA-marked devices are insufficient or unavailable.