MHRA is introducing a 12-month extension to the implementation of the future UK Medical Device Regulations, with the aim to bring the new regulations into force by July 2024.

The future medical device regulations represent a substantial reform of the current UK medical device regulatory framework. The government is therefore committed to ensuring that the future regulation is robust and implemented through a process that promotes system readiness andminimizes the risk of supply disruptions for UK patients.

For this reason, MHRA is putting in place a twelve-month extension to the current standstill period, in order to provide additional time to develop the legislation and support system readiness.

MHRA is now working on the development of future regulations and taking the next steps to implement the transitional provisions and post-market surveillance requirements, which the government intends to bring into force by Spring 2023.

THE TRANSITIONAL PROVISIONS

Today, the current Medical Device Regulations 2002 (UK MDR 2002) states that devices CE marked will continue to be accepted in Great Britain until 30 June 2023. Differently, the future 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.

So manufacturers will be able to continue to place CE marked devices on the Great Britain market after 1st July 2023. From July 2024, the transitional arrangements will apply for CE and UKCA marked devices placed on the Great Britain market.

For more information, see the MHRA website

THE SERVICES OF ENTE CERTIFICAZIONE MACCHINE

Through the new company ENTE CERTIFICAZIONE MACCHINE UK LTD, ECM widens the range of services that offers to companies wishing to export their products to the UK market.

ECM is currently preparing to get the necessary accreditations to carry out the conformity assessment procedures required for the issue of the UKCA mark.

We are available to provide information and present our services for the UK market. It is possible to contact our Sales Manager Eng. Diego Stevanella at diego.s@entecerma.it | mob. (+39) 393 2471040