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CE Mark

CEThe CE mark indicates compliance with all applicable European Directives.  CE marking is a mandatory regulatory requirement for a wide range of products including all electrical and electronic products and all radio communications equipment.

Should a Notified Body be used during the conformity assessment process, the Notified Body number must be shown after the CE mark.

Radio equipment that makes use of spectrum that has not been fully harmonised across Europe must display the alert mark.

The primary purpose of CE marking legislation is to prevent national legislation from presenting a barrier to the free movement of products within the European market, whilst ensuring an appropriate level of consumer and environmental protection.

CE marking Directives generally provide a significant level of flexibility regarding the way in which compliance with the essential requirements of the Directive may be demonstrated.  This flexibility allows unnecessary testing to be avoided and also enables new, innovative products to be brought to market, irrespective of whether applicable Harmonised Standards are available.

Once it has been determined that a product satisfies the essential requirements of all applicable CE marking Directives, the Manufacturer (or its Authorised Representative) may execute a Declaration of Conformity (DoC) before affixing the CE mark and placing the product on the European market.  This self-certification process is significantly less onerous and significantly more streamlined than the arrangements that existed before the New Approach, CE marking Directives came into force.

For some products (e.g. Medical Equipment) it is necessary to seek the expert opinion of a Notified Body as part of the process for determining compliance with European requirements.  But Notified Body services are generally very efficient at reviewing well structured submissions, so this additional step need not have a material impact on the overall approvals time-line.

In Europe, it is the responsibility of the Manufacturer (or its Authorised Representative) to ensure that product continues to satisfy regulatory requirements throughout its commercial life.  This makes it necessary for manufacturers to review the impact of any equipment design changes on the DoC. The flexibility built into most CE Marking Directives often makes it possible to use an Engineering risk assessment to determine whether or not testing will be required to ensure that regulatory compliance is maintained.

Manufacturers must also track the applicable regulatory requirements as CE Marking Directives and the associated Harmonised Standards continue to evolve and must evaluate the impact of these changes on the DoC.  From time to time, changes to regulatory requirements may trigger the need to retest product to new technical standards and in some instances it may prove necessary to modify the design of the product in order to maintain compliance.

Whether or not a Notified Body is involved as part of the process for determining compliance, it is important to ensure that the product approval is based on a robust evidence base that will stand up to scrutiny.  From time to time, National Regulatory Authorities will ask for evidence of compliance in accordance with their duty to undertake market surveillance and appropriate enforcement action.

We specialise in helping businesses to bring new, innovative products to market.

  • We will help you develop and deliver an effective approvals strategy that is consistent with your product marketing objectives
  • We will help you re-engineer your product to resolve any technical issues that may present a barrier to achieving compliance

If you would like to discuss how we can drive your project forward, please contact us.