06 Feb 2019

The UK Conformity Assessed (UKCA) marking is the new UK product marking that, subject to parliamentary approval, will be used for certain categories of products being placed on the UK in the event of a no deal. As part of accelerated planning for a no-deal Brexit, on the 2 February 2019, the government published guidance on using the UKCA marking post 29 March 2018. The guidance does not cover construction products, medical devices or rail interoperability which have been dealt with separately.

All UK companies involved in the manufacture, distribution or sale of CE marked products need to be aware of and start preparing for the changes which will be required under this new regime. The draft legislation implementing the required changes to existing UK legislation is expected imminently.

Post exit day, there will be a grace period in which the EU CE mark will continue to be fully recognised by the UK. Products which are already CE marked can therefore continue to be freely sold in the UK. However, products which have not already been CE marked will need to be assessed and affixed with a UKCA marking. Conversely, businesses exporting to the EU will need to ensure that products which have been assessed by a UK notified body are reassessed and remarked by an EU recognised conformity assessment body before being placed on the market. A more attractive alternative is to arrange to transfer existing conformity assessment files to an EU Notified Body in advance of 29 March 2019.

Below is a summary of the changes and implications for businesses.

Products sold in the UK

  • Products placed on the UK market before 29 March 2019 can continue to circulate without any changes to the marking being required
  • Post 29 March 2019 there will be a grace period during which products CE marked in conformity with EU standards can still be sold in the UK. The duration of the grace period is unclear and is likely to be subject to consultation
  • Where businesses have not completed the process of preparing a product to be placed on the market and intend to continue to rely on conformity assessment carried out by a UK-based conformity assessment body, the UKCA marking will be required instead of or as well as the CE marking after 29 March 2019 if products are also to be sold in the EU
  • Post-Brexit UK notified bodies will be granted new UK ‘approved body’ status. Approved bodies will assess products for the UK market against UK essential requirements. Immediately after exit day UK essential requirements will be the same as EU essential requirements. Existing EU harmonised standards will become UK designated standards, so the actual standards against which products are assessed will not change post-Brexit
  • After the grace period, businesses selling products on the UK market will, where required, need to have these assessed by a UK Approved Body before affixing a new UKCA marking enabling them to place a product on the UK market
  • Businesses relying solely on a self-declaration of conformity for the CE marking will also be able to use the UKCA marking based on self-declaration. For a time-limited period, manufacturers will be able to choose whether to use the CE mark or the UKCA mark or both.

Products sold in the EU

  • Post 29 March 2019 UK notified bodies will lose their status within the EU. As a result a conformity assessment carried out by UK conformity assessment bodies will no longer be recognised in the EU and UKCA marking will not be recognised by the EU. Products currently requiring a CE marking will continue to require a CE marking for sale in the EU
  • Products assessed by a body that was, prior to exit, a UK notified body will no longer be able to be placed on the EU market without reassessment and re-marking by an EU recognised conformity assessment body. Alternatively, businesses can arrange for their files to be transferred to an EU-recognised body pre-exit
  • Where CE marking is currently based on self-declaration of conformity by a business, self-declaration will still be possible, including when exporting to the EU.

Distribution issues

Post-Brexit day, in most cases UK companies distributing CE marked products brought in from the EU could be classed as importers for the purposes of the legislation. Similarly, EU distributors bringing in products from the UK may also be classed as importers. This status may impose additional obligations as set out in the existing EU legislation, including the requirement to check product compliance and to include the importer's name and address on the product or packaging.

The government has however already announced that there will be an 18-month transitional period during which importers of products from the EU into the UK may place this identification information on an accompanying document or label, rather than on the product itself.

Next steps

The draft legislation implementing the new requirements is expected shortly. We expect this to have to go through the affirmative process of being debated in both the House of Commons and the House of Lords, as is the case with the draft medical device legislation. Interestingly, that legislation, less controversially and much to the medical device industry's relief, continues to recognise the CE mark for the foreseeable future and does not contain any provisions on the UKCA mark.

Whilst it is comforting to see that UK conformity assessment requirements will mirror those in the current EU legislation, the UK is seemingly set on having a separate UK mark for most currently CE marked products.

To minimise disruption businesses should therefore consider the implications of the above on their products and supply chain, and keep a close eye on the draft legislation, and further details of the grace period.

Manufacturers may wish to consider placing as many CE-marked products on the market as possible prior to exit day, as well as deciding whether existing conformity assessment files should be transferred to an EU-recognised body before 29 March 2019, if they have not already done so. These steps will delay the immediate impact of Brexit, enabling manufacturers to put longer-term plans in place.

Distributors should consider whether their status may change under these new requirements and consider opening a dialogue with their suppliers, as commercial contract terms may require amending and updating to reflect the new position.

Clearly the introduction of the UKCA marking and the EU not accepting UK notified bodies CE markings will have an impact throughout supply chains, and on both exports and imports. Our product compliance team is actively advising businesses on the impact of these changes and what steps should be taken both now and longer-term, and would be delighted to assist businesses on working through these issues.