The MHRA has become aware of a number of medical devices being supplied on the UK market that do not comply with the requirements of the UK Medical Device Regulations 2002 (UK MDR 2002) or with the EU Medical Devices Regulation (EU) 2017/745 (EU MDR).
UK MHRA · August 10, 2026
Devices supplied without valid UKCA/CE conformity markings or certification: remove from use and place in quarantine (DSI/2026/007)
Original title: Devices supplied without valid UKCA/CE conformity markings or certification: remove from use and place in quarantine (DSI/2026/007)
MHRA enforcement notice requiring removal and quarantine of medical devices supplied without valid UKCA/CE markings or certification.
Published by UK MHRA. HealthSignal links to the original document; the summary above is extracted from the source text.