CE marking affects the supply of products and allows free movement and sale of goods throughout the European Economic Area. CE-marking is mandatory within this region and as part of the mandated requirements, it requires documentation in the form of a ‘Declaration of Conformity or commonly abbreviated to ‘DoC’ that states that the product meets all the applicable CE directives.
This DoC is required for each product and should be included either in the instruction manual, with the product or in the technical file. There are a total of 25 directives that may need to be considered prior to complete the Declaration and affixing the CE mark logo. The directives requiring CE marking affect the following type of product groups:
- Active implantable medical devices (excludes surgical instruments)
- Appliances burning gaseous fuels
- Cable-way installations designed to carry persons
- Construction products according to Regulation (EU) No. 305/2011 under specific rules
- Eco-design of energy-related products
- Electromagnetic compatibility
- Equipment and protective systems intended for use in potentially explosive atmospheres
- Explosives for civil uses
- Hot-water boilers
- In-vitro diagnostic medical devices
- Low voltage (Electrical safety)
- Measuring Instruments
- Medical devices
- Noise emission in the environment
- Non-automatic weighing instruments
- Personal protective equipment
- Pressure equipment
- Radio and telecommunications terminal equipment
- Recreational craft
- Restriction of the use of certain hazardous substances in electrical and electronic equipment RoHS 2
- Safety of toys
- Simple pressure vessels
Note: for some directives such as construction products and partly completed machinery the term declaration of conformity is replaced with “declaration of Performance” and Declaration of Incorporation” respectively.
So we now need to know how to get the ball rolling!
Step 1 – Identify what directives are applicable
Firstly not all products need to have CE marking. However, if the product does fit into the scope of a product group then it will require a declaration of conformity, if the product falls into multiple groups then typically a declaration for each group/directive will be required. One mentionable note to this is the Radio Equipment Directive (RED), medical devices, automobiles and military equipment each of which requires an exclusive declaration of conformity to those directives and these directives, in turn, require the assessment to other directives such as the EMC directive.
To identify all the directives that apply to the product and check each directive for the content requirements of the declaration of conformity.
The directives can be found free of charge on the European Commission (ec.europa.eu) website. For each product group there is a link and within each of these specific links is a downloadable language-specific version of the directive. Once on the new linked URL, there will be a link to the directive itself. For example for the Radio equipment directive:
Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC Text with EEA relevance. Applicable as of 13 June 2016.
This URL also has great useful links to assist with guidance documents and application guides.
Step 2 – Determine what information the directive requires for the declaration of conformity
For all product groups except construction products and partly completed machinery, (see note before) a CTRL+F or find on a page word search for the exact term “declaration of conformity”. As the search finds each term, make a note (copy and paste into a table or Excel sheet) of the article number and the text. Example as below for the RED directive: The 10th found “declaration of conformity” within the directive:
Article 10, section 4. “Manufacturers shall ensure that each item of radio equipment is accompanied by a copy of the EU declaration of conformity or by a simplified EU declaration of conformity. Where a simplified EU declaration of conformity is provided, it shall contain the exact internet address where the full text of the EU declaration of conformity can be obtained.
Step 3 – Create a CE directive declaration of conformity
Once all the required declaration of conformity information has been determined then it can comply with a declaration of conformity template and the product information can be entered. The basics of what is required for the RED directive can be found on our blog post “Radio Equipment Directive (RED) Declaration of Conformity (DoC)”. In addition check out our other blog post regarding the “New Legislative Framework (NLF) for CE mark” this includes information about how to complete a DoC and the required associated documentation for Electromagnetic Compatibility, 2014/30/EU directive.
Verify using the information in step 2 that all the required information within the directive specifications is encompassed within the Declaration of Conformity (DoC).
Alternatively, there are companies that specialise in product documentation such as “INSTRKTIV” (http://instrktiv.com/en/).
INSTRKTIV have created downloadable DoC templates for each of the 25 CE directives that can be found on their website.
INSTRKTIV helps organisations to create their instruction manuals. We advise on the legal requirements and create (write, illustrate, design, translate and publish) instructions.
INSTRKTIV also clarified that for CE EMC products. As of April 2016 it is allowed for EMC products to publish the manual online, except for the safety instructions. This is apparent from the above example for the Radio directive were which states
Where a simplified EU declaration of conformity is provided. It shall contain the exact internet address where the full text of the EU declaration of conformity can be obtained”
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