28th October 2022
12-Month Extension to the Implementation of the Future Medical Device Regulations
The future Medical Device Regulations is a substantial reform of the current framework as outlined in the government response. The government is committed to ensuring that there is a proportionate approach to its implementation, which supports system readiness and minimises the risk of supply disruptions for UK patients. Welsh Government are therefore introducing a 12-month extension to the implementation of the future Medical Device Regulations, with an aim to bring the new regulations into force by July 2024.
The current Medical Device Regulations 2002 (UK MDR 2002) states that the acceptance of CE marked devices on the Great Britain market ends on 30 June 2023. This has now changed. The transitional arrangements set out in the government response outline an extension to the recognition of CE marked medical devices placed on the Great Britain market, which is intended to be reflected within the UK MDR 2002, once it is amended.
The government intends to introduce legislation by Spring 2023 that will bring into force the transitional arrangements and post-market surveillance requirements as outlined in the government response. Bringing into force the new post-market surveillance requirements ahead of the wider future regulatory regime reflects the government’s priority of improving patient safety as part of the future Medical Device Regulations.
Manufacturers will be able to continue to place CE marked devices on the Great Britain market after 1 July 2023. From July 2024, the transitional arrangements will apply for CE and UKCA marked devices placed on the Great Britain market.
Read the full statement here.