A manufacturer can apply to supply a medical device that does not comply with the law to protect a patient’s health if there is no legitimate alternative available. This is called an exceptional use of a non-UKCA marked medical device. The same provision may be made for custom-made devices that have not complied with the standard conformity assessment procedure.
The MHRA may authorise manufacturers to supply a non-compliant device in the interest of the protection of health under Regulation 12(5) of the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). This also applies for active implantable medical devices in regulation 26 and for in vitro diagnostic medical devices under regulation 39(2)…
