Is CE marking mandatory?
Which products or product groups
There are about 25 CE Product Directives (New Approach Directives) and Regulations. It often happens that a product must comply with multiple directives at once.
An overview of the most important directives and regulations can be found in our Tool under “Downloads”.
Some products (groups) are covered by a directive, but CE marking is not mandatory. For these products, the Global Approach Directives apply.
Directives:
► Transportable pressure equipment (2010/35/EU)
► Equipment for sea-going vessels (96/98/EC)
► High-speed lines / train equipment (2008/57/EC)
Exceptions
Not all products may be CE marked. It is forbidden to affix CE marking to products not covered by at least one of the product directives and / or regulations. Also, when a product falls under the "exceptions" under a given directive, CE marking may not be affixed.
Who is responsible for the mark
A manufacturer or importer.
When a product has CE, the importer or manufacturer declares with its Declaration of Conformity that it meets the minimum requirements of the applicable directive (s). Your customer / buyer may assume that the product can be used safely.
Conformity
Examination of compliance with the CE marking regulations is largely covered by self-certification. This implies that the manufacturer or importer may need to carry out the necessary measurements and investigations themselves or may choose to outsource these measurements at an institute of his choice.
In certain cases, an EC type-approval is required and should be executed by a government-notified body (a so-called Notified Body). For example, with gas appliances and personal protective equipment. Behind the CE logo is a four-digit number. This four-digit code refers to the notified body that makes the assessment of production (EC surveillance). Which notified body belongs to which number can be found on the website of the European Commission in the NANDO database.
If you are required to go to a Notified Body for testing your product, you can see in Nando which companies are allowed to do these tests. You are free to choose which NoBo.
Harmonized standards
In order to provide the manufacturer (or importer) with a product conformity assessment, new standards are constantly compiled that are linked to the directives and regulations for the various product groups. These harmonized standards can be identified by the designation EN before the standard number.
Many of these standards provide the opportunity to omit a comprehensive risk analysis. Accurately following the articles of the norm may be based on the "presumption of conformity" with the relevant product legislation. The level of standards, in contrast to the directives and regulations, is in depth detailed and often technical.
Applying an EN standard is not mandatory but often it is a useful or an inescapable tool.
General product safety
In order to achieve a high level of product safety within the EU, a separate directive has been drawn up for consumer products that are not regulated by specific harmonized legislation, but also complies with the product requirements laid down in directives and regulations. Manufacturers may only market consumer products that are safe. For this directive, a RAPEX reporting system is in use that allows authorities to quickly be informed about dangerous products. In certain cases, the Product Safety Directive provides for the possibility of emergency measures within the EEA. The RAPEX system is gradually expanded for all non-food industrial products, not just consumer-oriented.
Example of a roadmap for CE marking
(1) What directives and possibly standards apply to your product
(2) Perform Conformity Assessment
(3) Apply safety requirements / risk analysis
(4) Draw up Technical Construction File
(5) Draw up Operating Instructions
(6) Draw up a Declaration of Conformity
(7) Apply CE marking
