Guidance

Using harmonised standards to place CE marked products on the market in Great Britain: UKCA and CE regimes

Updated 31 March 2026

Applies to England, Scotland and Wales

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Introduction 

A harmonised standard is a European standard that, once its reference is published in the Official Journal of the European Union, can be used for demonstrating that a product complies with relevant essential requirements of EU product legislation. 

Where the harmonised standard is identical to the Great Britain designated standard, manufacturers may rely on following harmonised standards to show that their product has met the essential requirements of the EU product legislation, when placing products on the Great Britain market, using  Conformité Européenne (CE) marking.

However, products which have followed harmonised standards and are placed on the Great Britain market using the CE marking do not benefit from a presumption of conformity with the essential requirements of the UK product regulations (as they apply in GB). Only UK Conformity Assessed (UKCA) marked products that have followed Great Britain designated standards do.

Check our guidance on designated standards for information on whether there is a difference between the harmonised standard and Great Britain designated standard. 

UK products where continued recognition of EU requirements applies

Continued recognition of EU requirements applies to the following UK product regulations:

When there is a difference between a Great Britain designated standard and a harmonised standard

When following a harmonised standard to place products on the Great Britain market using the CE marking, either of the following may apply:

  • there is no Great Britain designated standard  

  • part of a Great Britain designated standard is restricted so it does not exactly match the harmonised standard used 

Where this is the case, manufacturers following the harmonised standard will need to take additional actions before placing products on the Great Britain market. You must provide evidence in the form of technical documentation setting out how you have assessed and adequately protected against the risks of the product against the applicable health and safety requirements.

Where specific parts of a Great Britain designated standard have been restricted, manufacturers must be able to demonstrate how their product complies with those applicable essential health and safety requirements before placing the product on the Great Britain market. 

When stricter conformity assessment procedures apply  

Under certain UK product regulations (as they apply in Great Britain), a stricter conformity assessment procedure needs to be complied with before the CE-marked product can be placed on the Great Britain market, where one of the following applies:

  • there is no Great Britain designated standard

  • part of a Great Britain designated standard is restricted so it does not exactly match the harmonised standard used

For example, under regulation 39A(6) and (7) of the Toys (Safety) Regulations 2011 where there is a harmonised standard but no identical designated standard, the manufacturer using the harmonised standard cannot select Module A (Internal production control). Instead they must follow Module B (EU Type examination procedure), together with Module C (EU Conformity to type based on internal product control) of Annex II to Decision No 768/2008/EC, to place the product on the Great Britain market.

These additional requirements apply to the following UK product regulations:  

Products with type examination certificates

A type examination certificate is a verification by a conformity assessment body that the product meets required standards under legislation. For a CE-marked product with an EU type examination certificate, based on a harmonised standard that does not exactly match a restricted Great Britain designated standard, the manufacturer must provide evidence in technical documentation on how the risks are protected against before placing products on the Great Britain market.   

For UKCA-marked products, a UKCA type examination certificate, where required, is issued by a UK-approved body where this is based on compliance with a Great Britain designated standard. If this is later restricted, the manufacturer and the approved body must take appropriate action as set out under Module B conformity assessment procedures in the applicable  UK product regulations (as they apply in  Great Britain). This may involve a review of the certificate to ensure products placed on the Great Britain market on the basis of the certificate comply with the essential requirements.

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