UK Government Delays UK Medical Device Changes
The new Medical Device Regulations are going to be brought into force in July 2024, a delay of one year, according to an announcement by the Medicines and Healthcare products Regulatory Agency (MHRA).
This means that medical device products that have been authorised within the European Union with a CE mark as compliant with applicable medical devices regulations can still be placed onto the market in Great Britain until 30 June 2024, rather than the previously intended 30 June 2023.
The Government intends the new UK Medical Device Regulations to be built on five pillars:
- Strengthening the MHRA's power to act to keep patients safe.
- Making the UK a focus for innovation, the best place to develop and introduce innovative medical devices.
- Addressing health inequalities and mitigating biases throughout medical device product lifecycles.
- Proportionate regulation which supports businesses through access routes that build on synergies with both EU and wider global standards.
- Setting world leading standards – building the UKCA mark as a global exemplar.
The UK Government intends to introduce legislation by Spring 2023 to bring into force the new arrangements including transitional arrangements. From July 2024, the transitional arrangements will apply for CE and UKCA marked devices placed on the Great Britain market.
