BHTA calls for “urgent clarification” over how CE marking applies to medical device regulation
The Department for Business and Trade spotlight design verification and validation for medical device development within an ISO 13485:2016 framework. (DBT) yesterday announced its intention to indefinitely extend the use of CE marking alongside UKCA for British businesses, however, medical devices have not been included in this list.
The use of CE marking will apply to 18 regulations owned by DBT. This comes as part of a wider package of smarter regulations designed to ease business burdens and help grow the economy by cutting barriers and red tape.
The DBT stated that the Business Secretary had “acted urgently on this issue”, to prevent a cliff-edge moment in December 2024 when UKCA was set for entry. This intervention ensures some businesses no longer face uncertainty over the regulations and can cut back on unnecessary costs freeing them up to focus on innovation and growth.
Medical devices, however, have not been included in this list, with MHRA confirming they will still require UKCA marking in line with previously published transitional arrangements.
David Stockdale, CEO of the British Healthcare Trades Association, comments: “Medical device suppliers need urgent clarification on how the future of CE marking applies to our sector. Healthcare manufacturers are facing significant regulatory hurdles and the prospect of lifesaving products being removed from the UK market.
“While this extension provides welcome relief to companies across the UK, medical device suppliers continue to wait for clear and effective guidance – we stand ready to work with the Government to ensure the future of medical device regulation works for patients and businesses.”
The CE marking is already recognised in Northern Ireland. Businesses there will continue to enjoy unfettered access to the GB market and the EU single market. As such, the CE marking will be an acceptable method of demonstrating compliance for a wide range of goods on the UK market.
InnoScot Health’s Head of Regulatory Affairs Elaine Gemmell dispensed key advice on the fundamental part of the medical device manufacturing cycle, primarily aimed at Scottish SMEs, in an April 2023 webinar. Its aim was to spotlight design verification and validation for medical device development within an ISO 13485:2016 framework.
