The Department for Business and Trade has today announced an indefinite extension to the use of CE marking for businesses.
Business department announces indefinite CE mark recognition beyond 2024 deadline
As part of the government’s drive for smarter regulation, the extension will cut business costs and time required to place products on the market and benefit consumers.
Follows extensive engagement with industry, delivering on a key ask from businesses to ease burdens and boost growth for the UK economy
The Department for Business and Trade (DBT) has today announced its intention to indefinitely extend the use of CE marking for businesses, applying 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. Following extensive engagement with industry, British firms will be able to continue the use of CE marking alongside UKCA.
The Business Secretary acted urgently on this issue, to prevent a cliff-edge moment in December 2024 when UKCA was set for entry. This intervention will ensure businesses no longer face uncertainty over the regulations and can cut back on unnecessary costs freeing them up to focus on innovation and growth.
Business Minister Kevin Hollinrake said:
The Government is tackling red tape, cutting burdens for business, and creating certainty for firms – we have listened to industry, and we are taking action to deliver.
By extending CE marking use across the UK, firms can focus their time and money on creating jobs and growing the economy.
Tina McKenzie, Policy Chair of the Federation of Small Businesses (FSB) said:
It’s welcome to see the continued recognition of CE marked products. This will allow time for small firms to adjust to the UKCA marking system and focus on growing their business both at home and overseas.
Stephen Phipson, CEO of Make UK, the manufacturers’ organisation said:
This is a pragmatic and common sense decision that manufacturers will very much welcome and support. This announcement will help safeguard the competitiveness of manufacturers and aid the UK as a destination for investment.
It should bring more confidence about doing business in the UK and recognises the need to work with the reality of doing business. Make UK has worked extensively with UK Government pushing hard for this decision and we are pleased the ongoing engagement has delivered this positive outcome.
The extension will provide businesses with flexibility and choice to use either the UKCA or CE approach to sell products in Great Britain.
The Medicines and Healthcare Regulatory Agency (MHRA) has released a statement on CE marking recognition for medical devices and in vitro diagnostics.
Specific guidance around Medical Devices and IVDs
The extended recognition of CE marking announced this morning does not apply to medical devices or IVDs.
The government has already put in place legislation that amends The Medical Device Regulations 2002 (SI 2002 No 618, as amended) (UK MDR) to extend the acceptance of CE marked medical devices on the Great Britain market. More specifically, legislation now enables CE marked medical devices to be placed on the Great Britain market to the following timelines:
- general medical devices compliant with the EU medical devices directive (EU MDD) or EU active implantable medical devices directive (EU AIMDD) with a valid declaration and CE marking can be placed on the Great Britain market up until the sooner of the expiry of the certificate or 30 June 2028
- in vitro diagnostic medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (EU IVDD) can be placed on the Great Britain market up until the sooner of the expiry of the certificate or 30 June 2030, and
- general medical devices, including custom-made devices, compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR) can be placed on the Great Britain market up until 30 June 2030.32
For further information, please see the latest update on the implementation of the future regulations for medical devices.