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 email@example.com 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.
Sarah joined BHTA in April 2018.
After graduating with a Masters in English Language from De Montfort University, Sarah works across all BHTA publications (including AT Today and THIIS).