UK Government extends the recognition of the CE mark in Great Britain indefinitely
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Prior to this announcement, businesses placing certain products on the market, or putting them into service, in Great Britain faced a deadline of 11pm on 31 December 2024 after which those products would need to be marked with 'UKCA'.
UKCA is the UK's post-Brexit replacement for the EU CE mark and, if placed on a product, signifies that the product has been assessed to be in compliance with the relevant safety, health and environmental protection requirements applicable in Great Britain.
Now, businesses will be able to use either UKCA or CE for the following product categories (which cover a large number of consumer-focused products):
- toys;
- pyrotechnics;
- recreational craft and personal watercraft;
- simple pressure vessels;
- electromagnetic compatibility;
- non-automatic weighing instruments;
- measuring instruments;
- measuring container bottles;
- lifts;
- equipment for potentially explosive atmospheres;
- radio equipment;
- pressure equipment;
- personal protective equipment;
- gas appliances;
- machinery;
- equipment for use outdoors;
- aerosols; and
- low voltage electrical equipment.
The 31 December 2024 deadline was itself the result of a number of previous delays to the introduction of the UKCA mark requirement following the UK's departure from the EU.
The imposition of the UKCA mark as a mandatory requirement had been opposed by businesses and industry lobby groups who saw it as an example of unjustified post-Brexit 'red tape' and something which only served to impose additional costs. This was especially the case given that many businesses continue to operate in both the UK and the EU (or, if only in the UK, they operate in both Great Britain and Northern Ireland, with EU requirements still applying in the latter), thus necessitating compliance with both regimes and inclusion of both the UKCA and the CE mark even where space may be an issue.
The UK Government's announcement will undoubtedly be welcomed by those organisations critical of the requirement. However, many are likely to be frustrated by the fact that businesses which have sought to ensure that they will be in a position to meet the 31 December deadline (by complying with the UKCA requirement before it became mandatory) will have incurred costs that other businesses, including those which were simply unaware of the pending new requirement, will now be able to avoid.
Such costs will have included those relating to amending product designs, changing packaging and materials and undertaking conformance testing (to the extent that they were able to navigate the bottlenecks in the UK certification industry).
One industry not impacted by the change is the medical device industry, as confirmed by the MHRA in its announcement. The MHRA noted that the government had already put in place legislation to extend the acceptance of CE marked medical devices 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.
However, those in the medical device industry will undoubtedly be watching this space to see if the requirement for UKCA marking on medical devices will similarly be abandoned.
It remains to be seen how the UK will ensure that businesses placing products on the market in Great Britain will be able to demonstrate compliance with any new UK requirements where these do not also exist in the EU (and are therefore not covered by the affixing of the CE mark).
There are different rules for Northern Ireland. These are unaffected by the announcement because the CE marking is already mandatory in Northern Ireland.
If you would like to discuss this topic with a Fieldfisher lawyer, please contact Aonghus Heatley or Taly Dvorkis, Directors in the firm's London office. Aonghus and Taly regularly advise businesses on UK regulatory requirements in the chemicals, consumer, life science, technology, environmental, medical and food and beverage industries.