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declaration of conformity definition

Our experts can provide businesses with expertise, advice and help when preparing a Declaration of Conformity for their products. The team here at Conformance are able to provide their services across both the UKCA and CE Marking processes, lending a helping hand when producing a Declaration of Conformity for either of these marks.

What is a Declaration of Conformity?

The Declaration of Conformity is a legal document in which the manufacturer or authorised representative signs to state that all CE Marked products sold in the European Union, meets all of the requirements of the applicable EU directives and regulations.

The Declaration of Conformity must be issued by the “manufacturer” or their “authorised representative”. However, this is not necessarily the person or company who actually made the product.

What Does a Declaration of Conformity Do?

The Declaration of Conformity allows an enforcement authority to identify who is responsible for a product and the activities that person claims to have done to CE mark it. In making a senior person put their signature on a piece of paper, it concentrates their mind on whether or not the product really does comply and therefore makes compliance more likely. 

According to The New Legislative Framework (NLF) Commission Decision 768/2008/EC (Recital 26) "Any economic operator that either places a product on the market under his own name or trademark or modifies a product in such a way that compliance with applicable requirements may be affected should be considered to be the manufacturer and should assume the obligations of the manufacturer.”

signature

Effectively, if you re-brand a product or modify it such that safety might be affected, you become the manufacturer and should issue a Declaration for the ‘new’ product. This includes importing a product from outside the EU that was not CE marked by its original manufacturer.

What Should a Declaration of Conformity Include?

The Declaration of Conformity document needs to include the following:

  • Name/address of manufacturer (and of responsible person where applicable)
  • Model and/or serial number of equipment
  • List of relevant directives
  • List of standards used, with dates + amendments
  • Declaration statement
  • Notified body details (if required)
  • Name and position of person signing
  • Signature
  • Date

How do I get a Declaration of Conformity?

Conformance has assisted thousands of companies through the CE marking process and helped them produce a Declaration of Conformity to accompany their products. 

Draft copies of the model structure for the EU Declaration of Conformity can be purchased from our shop

We now have a range of UKCA Declaration templates, suitable for machinery and electrical products including options on radio equipment, EMC & RoHS. All the declarations are supplied with guidance notes and are available to purchase from our online shopClick here to see an example.

Further Information on the Declaration of Conformity

Test houses and Notified Bodies do not issue a Declaration of Conformity because they do not have overall responsibility for the product. They issue certificates stating their opinion about limited aspects of conformity.

The manufacturer does not need to be based in the EU, but certain Directives require an EU-based contact point to be identified to act as a contact point for the EU authorities (e.g., the Machinery Directive; see below).

The NLF directives require a single Declaration of Conformity document for all of the applicable directives. They specify a consistent format and content of the Declaration of Conformity in a “model structure” with the items numbered as listed below.

  • The unique identification of the product.
  • Name and address of manufacturer or authorised representative taking responsibility for the product
  • The statement “This declaration of conformity is issued under the sole responsibility of the manufacturer”.
  • Description of product allowing traceability.
  • The declaration of conformity statement with a list of the applicable CE marking directives and regulations the product complies with.
  • Details of the standards if any have been applied.
  • Details of notified bodies as required in the conformity assessment procedures, their conformity assessment procedures and certificates (e.g. for product type approval or quality system assessment). Notified Body involvement not specified in the directives should not be declared.
  • The signature of the senior person representing the manufacturer or authorised representative.
  • Any additional information.

This is to make Declarations of Conformity easier to understand, especially if they are in another language or alphabet.

The Declaration of Conformity must be translated into an official languages of each EU member state where the product is placed on the market.

Directives that predominantly apply to professional equipment require the Declaration of Conformity to be supplied with the product. (e.g., Machinery Directive, ATEX Directive, RED (Radio Equipment Directive) Those predominantly for consumer equipment do not (e.g. Low Voltage directive, EMC directive.) This reflects the end users interest in the Declaration of Conformity.

Some directives require special additional information on the Declaration of Conformity:

2000/14/EC  Noise Emissions of Outdoor Equipment Directive Sound power level 
2009/48/EC Toy Safety Directive Colour image of the toy
2014/34/EU ATEX Directive ATEX marking code
2013/29/EU Pyrotechnic Articles Directive Registration number
2014/53/EU Radio Equipment Directive (RED) Description of accessories, components and software
2014/68/EU Pressure equipment Directive (PED) Description of the pressure equipment constituting the assemblies and their conformity assessment procedures
2006/42/EC Machinery Directive  Name and address of EU contact point

The Machinery Directive’s additional information is worthy of special mention. The Declaration of Conformity must identify the name and address from where the EU authorities can obtain the technical documentation for the product and this must be an address in the EU. Manufacturers outside Europe may find our sister company Authorised Representative Service useful in helping them to fulfill this requirement.

Why Choose Conformance?

Conformance is the UK's leading independent specialist in Product Safety, CE Marking and UKCA Marking. For more than 30 years, we have specialised in helping companies, small and large, to meet the regulations that their products are required to comply with in their markets and industries.

Get in touch with us today to find out more about our Declaration of Conformity services.

Introduction to CE and UKCA Marking your Products

This course will guide you through the complete CE marking process, from design considerations and finding the right standards to completing all the necessary documentation.

Read more: Introduction to CE and UKCA Marking your Products

CE and UKCA Marking Machinery & Industrial Equipment

This course will give you an understanding of how to carry out machinery assessments, including finding and applying the relevant standards, and the documentation that must be provided.

Read more: CE and UKCA Marking Machinery & Industrial Equipment

Machinery Risk Assessment Training

This course explains the role of standards in the risk assessment process, to enable designers and project managers to carry out the risk assessment in the most efficient way.

Read more: Machinery Risk Assessment Training

Pressure Equipment Directive Training Course

This course provides an overview of the Pressure Equipment Directive, where you will learn who should take responsibility, how to find and apply standards, what documentation you need to produce.

Read more: Pressure Equipment Directive Training Course

ATEX Compliance & Risk Assessment Course

This course will take you through the CE and Ex marking process in detail. You will gain an understanding of the requirements, including the various options for ensuring equipment is safe.

Read more: ATEX Compliance & Risk Assessment Course

CE & UKCA Marking Electrical Equipment Training Course

This course will explain who is responsible for CE marking, and what should be done to carry out the process correctly, as well as looking into the directives and standards involved.

Read more: CE & UKCA Marking Electrical Equipment Training Course

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