The UK’s Department for Business and Trade (DBT) has announced an indefinite extension to the use of CE marking for businesses in the UK, beyond the 2024 deadline. The aim is to cut business costs and products’ time to market. The government intends to implement major reforms to the current regulatory framework for medical devices, with core parts set to apply from 1 July 2025.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated the way to report adverse incidents involving medical devices. Now manufacturers can submit incidents via the new MORE portal. A new registration is required.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced a 12-month extension to its substantial reform of the Medical Device Regulations, which will now come into force by July 2024.
Wellcome has awarded £1.8m to the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) so that they can investigate and produce guidance on regulation of digital mental health tools.
