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CE mark to change to UKCA mark

MHRA announces overhaul of medical device regulation

June 27th 2022

Tagged: Dispensary guidance news

By Ailsa Colquhoun

The CE mark for medical devices will be replaced by a UKCA mark, the MHRA has said.

The recertification follows the UK’s departure from the EU and forms part of new regulatory plans to strengthen the regulation of medical devices.

Other changes aim to improve equitable access to medical devices, particularly for diverse populations, and to regulate for smartphone Apps used in health management.

Medical devices include technologies such as insulin pumps and implants.