Big news for manufacturers: the UK Government announced on 1 August 2023 that it will indefinitely recognize the EU’s product conformity assessment mark (the “Conformité Européenne” or “CE” mark), with respect to a range of manufactured goods placed on the UK market. 

The move is a significant reversal of the UK’s previous, post‑Brexit policy.  In a bid to separate the UK’s internal market from the European market, the UK promised to phase out CE marks for products marketed in England, Scotland and Wales (Great Britain or “GB”), and replace them with an equivalent “UKCA” mark.  However, the project suffered from numerous delays, and the UK repeatedly extended the deadline for transitioning from the CE mark to the UKCA mark, before the recent announcement that the UK will accept CE marks indefinitely.  Despite this change of policy, the UK has not abandoned the UKCA mark yet, and manufacturers may still choose to use it.  Even so, it is not obvious why a manufacturer would choose conformity assessment that is recognized only in the UK over (or even as well as) conformity assessment that is recognized across the UK and the EU.  What remains to be seen is whether differences between the UK and EU conformity assessment standards will lead to a kind of “forum shopping” by manufacturers. 

Also, and of significant importance for medical device manufacturers, the indefinite extension of CE mark recognition does not (at least currently) cover medical devices nor in vitro diagnostic medical devices (“IVDs”).  The Medicines and Healthcare products Regulatory Agency (“MHRA”) is separately consulting on international recognition of foreign approvals (including CE marks) in the medical device space.

Background

EU law provides standards that products in specific categories must meet before they can be placed on the market in the EU.  These standards cover issues like product safety, durability, eco‑design, etc.  There are standards for a wide — and growing — range of different products, from electrical goods to construction materials, and from medical devices to toys.  Before placing a product on the market, a manufacturer must assess its product against the relevant standards, and mark their products with the CE mark to indicate conformity. 

Following the UK’s departure from the EU (“Brexit”), the UK proposed a new conformity assessment scheme for products marketed in GB, to replace the European CE marking scheme.  The basic process was identical: before placing manufactured goods on the market in GB, manufacturers would be required to assess their products against the relevant UK standards, and mark their products with the “UK Conformity Assessment”, or “UKCA” mark.[1]  

As of 1 January 2021, the UKCA mark became available for businesses to use voluntarily.  The UK planned to phase out the use of the CE mark gradually, eventually completely replace it with the UKCA mark.  Initially, the UKgave businesses outside of the medical device space a transition period until 1 January 2022 to switch from CE marks to UKCA marks.[2]  However, the Government had delayed the general CE mark “sunset date” multiple times, most recently until 11 pm on 31 December 2024.

If the UK had finally implemented the UKCA mark scheme, manufacturers selling products in both GB and the EU faced the prospect of needing to undergo two conformity assessments, culminating in two separate conformity assessment marks for a single product, increasing the cost burden associated with bringing a product to market in both jurisdictions.

However, in the face of consistent opposition from business, the UK has changed tack and elected to indefinitely permit businesses selling electronic, industrial and consumer products to use either UKCA or CE marks when placing products on the GB market.

New Position

Specifically, the UK’s Department for Business and Trade (“DBT”) will indefinitely extend CE mark usage for 18 categories of products, including: toys; pyrotechnics; recreational craft and personal watercraft; simple pressure vessels; non-automatic weighing instruments; measuring instruments; measuring container bottles; lifts; equipment for potentially explosive atmospheres (“ATEX”); radio equipment; pressure equipment; personal protective equipment (“PPE”); gas appliances; machinery; equipment for use outdoors; aerosols; low voltage electrical equipment and goods subject to electromagnetic compatibility regulations. 

The UK’s Business Minister, Kevin Hollinrake, stated that this move was intended to “cut burdens” and establish certainty for businesses, while avoiding a “cliff-edge” moment when the CE mark was due to be phased out in December 2024.  Businesses welcomed the new policy, with the CEO of Make UK (the manufacturers’ organization), commenting that “this is a pragmatic and common sense decision that manufacturers will very much welcome and support” and “will help safeguard the competitiveness of manufacturers and aid the UK as a destination for investment.

It appears that both the CE mark and the UKCA mark will be available to manufacturers going forward, although due to the additional burden of obtaining the two separate marks, and the much wider use‑case for the CE mark, it seems unlikely that many businesses will use the UKCA mark.

Looking Forward

This development raises a number of questions.

As noted above, the UK has promised to recognize the CE mark for 18 categories of products.  However, that list does not cover every category of regulated product.  This has created huge uncertainty for key product sectors, like construction, rail products, marine products, and others.  The UK promised that specific plans for those other products would be communicated in due course.

Many companies spent considerable sums on UKCA mark compliance, in order to meet the previous transition deadline.  Will they be entitled to receive any form of reimbursement?  The lack of reference to such considerations in the UK’s announcements suggests that this is unlikely.

What will happen if/when changes to UK and EU conformity standards mean that those standards diverge or even conflict?  The CE mark indicates compliance with EU standards and legislation, not those in the UK.  Although these are currently largely aligned, that may change in the future.  Are distributors and consumers to take the view that the CE mark indicates compliance with UK law when a product is sold in GB?  If so, this could create substantial confusion if standards vary widely and it is unclear from a CE mark under which set of standards a product has undergone conformity assessment.

Notably, the indefinite extension of CE mark recognition does not cover medical devices nor IVDs.  The MHRA confirmed this position in a follow-up announcement and restated its existing plan to recognize the CE mark for medical devices and IVDs until 2028 and 2030, respectively, at which point manufacturers will be required to use the UKCA mark.  The MHRA did, however, note that it is reviewing its position on future acceptance of the CE mark, taking on board stakeholder feedback, and will publish an update in due course.  Will there eventually be a permanent, separate  conformity assessment scheme for medical devices from 2028 onwards (i.e., a mandatory UKCA mark scheme), or does the UK intend at some point between now and 2028 to also scrap these deadlines in favour of indefinite CE mark recognition? 

If you would like to discuss the new CE mark policy and what it may mean for your company’s operations, please contact the Covington Team.


[1] EU product conformity law and standards continue to apply in Northern Ireland under the terms of the Northern Ireland Protocol.  As such, the UK Government introduced a hybrid system in Northern Ireland:  CE marking would be required for all goods, while a “UKNI” mark would also be required for certain goods subject to conformity assessment by a third‑party assessment body based in the UK.  This position appears unchanged by the UK Government’s decision to recognize CE marking in GB.

[2] Manufacturers were still permitted to have both the UKCA mark and CE mark on the same product.

Photo of Seán Finan Seán Finan

Seán Finan is an associate in the Life Sciences team.  His practice covers environmental, food and beverage and pharmaceutical regulation. 

Seán has specific experience in a number of key areas for EU and UK clients in the food and beverage, pharmaceutical, cosmetic and…

Seán Finan is an associate in the Life Sciences team.  His practice covers environmental, food and beverage and pharmaceutical regulation. 

Seán has specific experience in a number of key areas for EU and UK clients in the food and beverage, pharmaceutical, cosmetic and consumer goods industries, including:

  • General food regulation; novel food regulation; genetically modified and “precision bred” products;
  • Advertising claims, particularly environmental claims and “greenwashing”;
  • Environmental and ESG compliance issues (Extended Producer Responsibility, ); and
  • Chemicals legislation (REACH, CLP, Biocides).

Seán is qualified in both England & Wales, and the Republic of Ireland.

Photo of Sarah Cowlishaw Sarah Cowlishaw

Advising clients on a broad range of life sciences matters, Sarah Cowlishaw supports innovative pharmaceutical, biotech, medical device, diagnostic and software technology companies on regulatory, compliance, transactional, and legislative matters.

Sarah has particular expertise in advising on legal issues presented by digital health…

Advising clients on a broad range of life sciences matters, Sarah Cowlishaw supports innovative pharmaceutical, biotech, medical device, diagnostic and software technology companies on regulatory, compliance, transactional, and legislative matters.

Sarah has particular expertise in advising on legal issues presented by digital health technologies, helping companies navigate regulatory frameworks while balancing challenges presented by the pace of technological change over legislative developments.

Sarah is a co-chair of Covington’s multidisciplinary Digital Health Initiative, and is the Graduate Recruitment Partner for Covington’s London office.

Sarah regularly advises on:

  • classification determinations for software medical devices, including on developments resulting from the implementation of the EU Medical Devices Regulation;
  • legal issues presented by digital health technologies including artificial intelligence;
  • general regulatory matters for the pharma and device industry, including borderline determinations, adverse event and other reporting obligations, manufacturing controls, and labeling and promotion;
  • the full range of agreements that span the product life-cycle in the life sciences sector, including collaborations and other strategic agreements, clinical trial agreements, and manufacturing and supply agreements; and
  • regulatory and commercial due diligence for life sciences transactions.

Sarah’s pro bono work includes advising the Restoration of Appearance and Function Trust (RAFT) on the classification of a wound healing product containing human blood derivatives, and assisting in a project aimed at improving regulatory systems for clinical trials of drugs and vaccines for neglected diseases in developing countries.

Sarah has been recognized as one of the UK’s Rising Stars by Law.com (2021), which lists 25 up and coming female lawyers in the UK. She was named among the Hot 100 by The Lawyer (2020) and was included in the 50 Movers & Shakers in BioBusiness 2019 for advancing legal thinking for digital health.

Sarah has undertaken several client secondments, including to the in-house legal department of a multinational pharmaceutical company.

Photo of Dan Spivey Dan Spivey

Dan Spivey is an associate in the Life Sciences Regulatory team. Dan advises clients in the pharmaceutical, healthcare, medical device, and food and beverage sectors on a range of regulatory matters.