When is CE Marking mandatory for machinery?
The CE marking is a symbol, by which the manufacturer or legal representative declares under their responsibility that the product they are marketing, after carrying out an assessment procedure, has complied with the essential health and safety requirements set out in the relevant product regulation.
It is not a mark of origin. In other words, it does not mean that it has been manufactured in the European Union, but rather that the product placed on the EU market complies with European safety legislation.
It affects products that have a directive defining specific design, safety and manufacturing requirements.
The CE marked It is obligatory, except for products not covered by a directive, referred to as new approach directives, that regulate it and require the product to include such marking. The time at which it must be affixed is just before it is placed on the market or put into service in the European Union.
It is independent of whether the product has an economic benefit or is free; and also independent of the sales technique, whether through catalogues or e-commerce, as long as the final market is the EU.
It is primarily the manufacturer's responsibility, but the representative, importer and distributor also share some responsibility. They all have to ensure that they place a product on the market that is safe for the end-user.
CE Marking Legislative Framework
The aim of CE marking is for everyone to adhere to the same rules, both manufacturers and end-users. Let's consider that we are putting products on a market made up of 27 different countries, with 27 different legislations, and it is necessary to unify criteria. Therefore, both technical and regulatory harmonisation is sought.
To this end, New Approach Directives were created for certain products, establishing safety requirements that are the same in all countries, as well as a common technical environment that ensures confidence that tests carried out in any of these countries will have equivalent validity.
The products that must bear the CE marking are those established in the New Approach Directives, the origin of which is Regulation 765/2008 and Decision 768/2008, which set out the evaluation procedures.
If CE marking is applied to a product that does not have a New Approach Directive, it will be considered as misrepresentation to the consumer, as they might believe that the product complies with legal requirements that do not actually exist. This does not mean that it does not need to comply with any regulations, as any product that can be purchased by a consumer in the EU must comply with Directive 2001/95/EC, relating to general product safety.
Most industrial products require this certification. However, there are other products to which it does not apply.
Products that do not carry CE Marking
Answering the question When is CE marking compulsory? Do all products need it? Definitely not. Some products do not have CE marking, however, this does not exempt them from complying with safety requirements or having technical documentation related to the product, such as the user manual and instructions or the technical specifications sheet.
Indeed, there are products that must comply with the Directive 2001/95/EC on General Product Safety even though they do not carry CE marking and pass laboratory tests.
It is the case, for example, of the Hygiene mask approval, from bicycles, from some sports products, or from childcare items.
They will also not bear the CE mark Bespoke medical devices as these are manufactured according to the needs of a specific patient, not to a specific manufacturing standard.
Should you have any doubts, the manufacturer or importer can contact our technical team to ascertain which legislation would be mandatory for them, whether product testing is required, or if mandatory CE marking is necessary.
At Grupo TICE we specialise in Industrial Safety y nos especializamos en el CE Marking Machinery.
