Guidance

Using harmonised standards for placing CE marked products in Great Britain

Published 3 February 2025

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.  

Products which have followed harmonised standards and are placed on the GB market relying on recognition of 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 UKCA marked products that have followed GB designated standards do.  

However, where the harmonised standard is identical to the GB 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 GB market, relying on CE recognition.

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

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

When there is a difference between a GB designated standard and a harmonised standard 

It is very unlikely that following the harmonised standard will be sufficient to demonstrate compliance with the relevant essential requirements of the EU product regulation before placing the product on the GB market where either of the following applies: 

  • there is no GB designated standard 
  • part of a GB designated standard is restricted so it does not exactly match the harmonised standard used

In this case, manufacturers following the harmonised standard will need to take additional actions before placing products on the GB 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 EU essential safety requirements,   

Where specific parts of a GB designated standard have been restricted, manufacturers must be able to demonstrate how their product complies with those particular essential requirements of the EU product legislation before placing the product on the GB market.

When stricter conformity assessment procedures apply 

Under certain UK product regulations (as they apply in GB), where there is no GB designated standard or part of a GB designated standard is restricted so it does not exactly match the harmonised standard used, a stricter conformity assessment procedure needs to be complied with before the CE marked product can be placed on the GB market.  

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 GB market.

These additional requirements apply to the following UK product regulations: 

Products with type examination certificates  

For a CE marked product with an EU type examination certificate, based on a harmonised standard that does not exactly match a restricted GB designated standard, the manufacturer must provide evidence in technical documentation on how the risks are protected against before placing products on the GB 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 GB 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 GB). This may involve a review of the certificate to ensure products placed on the GB market on the basis of the certificate comply with the essential requirements.

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