MHRA: Implementation of British Medical Device Regulation Delayed
On 25 October 2022, the UK Regulatory Agency MHRA, announced that the introduction of the future UK Medical Device Regulation will be delayed by twelve months. The intended date for introduction of the new and standalone regulation is now set for July 2024.
As the new medical device regulation entails a profound change of the previous law, the transition should be able to be carried out without disruption of care for UK patients. According to the MHRA. this goal cannot be achieved by 20 June 2023.
At the end of June 2022, the MHRA published a government statement on the future regulation of medical devices in the UK. It outlines the planned changes, including the transitional arrangements for CE and UKCA marked devices placed on the market in the UK. In this regard, manufacturers will still be allowed to place CE-marked medical devices on the market after 1 July 2023. The transitional arrangements for CE- and UKCA-marked devices will apply in the UK from July 2024.
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