Clarification on continuation of CE marking in UK 7 Aug 2023
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.
However, this change applies only to the 18 regulations for which the DBT is responsible and therefore does not apply to medical devices or in vitro diagnostics. Companies can continue to use the CE marking alongside UK Conformity Assessed (UKCA) marking.
Legislation is already in place to extend the acceptance of CE-marked medical devices on the GB market, as confirmed by the Medicines and Healthcare products Regulatory Agency (MHRA) in a statement on 1 August 2023.
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.
If you are looking for advice on taking your medical device or in vitro diagnostic through the evolving UK regulatory process to commercialisation, PMC has experts on hand to guide you. Please contact us for an initial chat via firstname.lastname@example.org or T: +44 (0) 208 168 1668.