The government has introduced 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.
In announcing the extension, the government says it 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.
The government says it 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.
The guidance on Regulating Medical Devices in the UK will be amended to reflect the extended timelines for implementing the future Medical Device Regulations.
The government is working with industry, the trade associations, and the devices community to support the effective implementation of the new regime and says the legislation will be accompanied by guidance to support developers in the interpretation of the new regulations. To build on its existing expert groups and in partnership with patient and industry focused groups, the government will run a series of workshops, commencing this year, to refine its thinking and support the implementation of the new regime.
Read the full decision document here.
See all updates from the The Medicines and Healthcare products Regulatory Agency (MHRA) here -https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
