Last Updated on 23/08/2023 by Sarah Sarsby
Exceptional Use of Non-UKCA-Marked Medical Devices: In this guidance MHRA outlines how manufacturers can apply for approval to supply non-compliant medical devices on humanitarian grounds. This usually applies to medical devices (including certain custom-made devices), that do not comply with the law, to protect a patient’s health, but for which there are no legitimate alternatives available. It is a vanishingly rare exception, reflected in the application process, which requires input from both manufacturer and clinician on an individual patient-by-patient basis (please email dts@mhra.gov.uk for more information).
Exemptions From Devices Regulations During the Coronavirus (COVID-19) Outbreak: In this guidance MHRA outlines how manufacturers can apply for fast-track approval of medical devices during the COVID-19 pandemic which MHRA has indicated might be used, during a period of regulatory flux and/or UK AB/EU NB capacity shortfall.
