At the end of last month the UK government announced a range of proposed measures to ease the transition to the new UK Conformity Assessed (UKCA) regime that will replace the EU’s CE marking regime for the Great Britain market (England, Scotland and Wales) in respect of most types of CE marked products from the start of 2023.  Note, products sold in Northern Ireland will continue to need to be CE marked as a result of the Northern Ireland Protocol, even once UKCA marking has become mandatory across the rest of the UK.

The changes announced include:

  • Enabling conformity assessment activities undertaken by third party assessment bodies before the end of 2022 for CE certification to be used as the basis for UKCA marking (as opposed to requiring the involvement of a UK approved body). This should help to reduce the re-testing cost and burden on manufacturers.  Products will still need to bear the UKCA mark and will need to undergo conformity assessment by a UK approved body upon expiry of the CE certificate or by 31 December 2027, whichever is sooner. 
  • Allowing CE marked products physically imported into Great Britain under contract by the end of 2022 and held in stock to be treated as “placed on the market”, meaning that they can continue be sold to GB customers without needing to meet UKCA requirements.  This appears to be a relaxation of the usual interpretation of “placing on the market” which requires products to have been “made available” or “supplied”.
  • Confirming that spare parts need to comply with the same conformity assessment requirements that were in place at the time the original product they are intended to repair was placed on the market.  It is hoped this will help address concerns around the availability of spare parts in Great Britain post-Brexit.
  • Extending the current transitional provisions which allow for the UKCA mark to be included on a sticky label or in an accompanying document, rather than on the product itself, until 31 December 2025.

While these changes will apply to most types of CE/UKCA marked products, different rules will apply in respect of certain categories, including both construction products and medical devices.  (Note, in respect of medical devices the government recently published its response to its consultation on the future regulation of medical devices in the UK.) 

The additional flexibility that these measures provide will no doubt be welcomed by many businesses who were struggling to meet the original UKCA marking deadlines, particularly because of capacity issues with UK approved bodies.  

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Rachel MacLeod is an Associate in Baker McKenzie's London office. She advises companies on the "cradle-to-grave" regulation of a broad range of products sold on the EU and UK markets and also advises companies on how to comply with their operational environmental and health & safety obligations.

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Graham Stuart is a partner in Baker McKenzie's London office specialising in product regulation and environmental, health and safety law. Graham advises on the regulation of pharmaceuticals, medical devices, chemicals, food, and a wide range of consumer and industrial products, acting for clients in connection with global integrations and reorganisations; product manufacturing, marketing, supply and distribution; EU and UK product authorisation regimes; non-conformities, regulatory investigations and prosecutions. His practice also covers operational environmental, health and safety matters for industrial and manufacturing facilities; the assessment and management of environmental risk in complex multi-jurisdictional projects, mergers and acquisitions; and climate change law and emissions trading.

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