CE Marking: Trusted CE Certification Company
What is CE marking / CE certification?
CE marking and certification is required for many products - including production tools, medical devices and equipment - that are supplied to, or sold in, the European market.
The CE marking process involves assessments and testing to certify that your product adheres to European legislation. The legislation is fairly complex, but in this guide we’re going to cover the stuff you really need to know:
- How do you get a CE mark?
- What products need CE marking?
- Can you self-certify?
- How can you check if your CE mark is still valid?
- How much does CE certification cost?
- What is the manufacturer’s Declaration of Conformity?
- What are the penalties and who enforces them?
- What’s the difference between EC and CE certificates?
- What will happen to CE marking after Brexit?
How do you get a CE mark?
The specific process which is required for CE marking will depend on the product itself. In general, there are six steps to compliance:
- Identifying the relevant directive for your product.
- Ensuring that your product complies with the essential requirements of the directive which applies to it.
- Checking if an independent conformity assessment needs to be conducted for your product.
- Testing your product for conformity, including carrying out a risk assessment.
- Preparing the technical documentation required by the directive.
- Affixes the CE mark and creating and signing an EC (European Commission) Declaration of Conformity.
Got a CE marking enquiry or project you want to discuss? We’re happy to help answer questions on a zero-obligation basis. Get in touch using the form.
What products need CE marking?
CE marking is mandatory for a wide variety of products supplied to, or sold in, the European single market. Applicable products are covered by the scope of at least one of the EC’s New Approach Directives; such as the Low Voltage Directive, EMC Directive and Machinery Directive. Products range from electrical equipment to machinery, measuring instruments, personal protective equipment and toys.
A full list of product categories can be found here.
Can you self-certify?
It is possible for manufacturers to assess the conformity of their own products. Self-certification can reduce costs, but it should be remembered that testing processes and defining the legal frameworks which apply to your product can be complex. CE marking experts such as IES offer an efficient strategy to achieving compliance, and a wealth of experience in areas such as knowledge of standards, technical record keeping and CE marking timelines.
Read about how we provided CE marking services for a Japanese Quick Die Changer (QDC) in an Italian automotive part manufacturing plant.
How can you check if your CE mark is still valid?
You can see if your CE mark is still valid by referring to the relevant documentation; the Declaration of Conformity and Technical File. If a Notified Body – that is, a third party such as IES, which is required to assess certain products for CE marking compliance – issued the certificate which is part of the documentation, you should contact them to confirm validation.
How much does CE certification cost?
The cost of CE marking your product will vary significantly, according to both the product and your in-house capabilities. The type and intended use of the product, as well as the risk attached to using it, can also impact on cost. Which directives and relevant EU legal requirements apply to the product will influence cost. Finally, whether a manufacturer has the resources to complete some or all of the conformity assessments and create the Technical File independently will also impact on the overall investment needed for CE marking.
Find out all you need to know about CE Marking and UKCA marking with our full guide.
What is the manufacturer’s Declaration of Conformity?
Every CE mark must have a Declaration of Conformity document which sets out the directives and standards that products meet. It also includes key details about the product and the manufacturer; such as the product’s serial number and brand, and the name and address of the manufacturer.
The Declaration of Conformity can be issued by a Notified Body, or in the case of some directives, by the manufacturer or importer of the product into the EU, as a self-declaration. A copy of the Declaration of Conformity must be retained by the manufacturer for at least ten years after the last product has been placed on the market.
What are the penalties and who enforces them?
Each European Union member state has its own nominated public authority responsible for market surveillance and enforcement. They work to prevent the misuse of the CE mark and ensure product safety. In the UK, these market surveillance authorities include; Trading Standards Services, the Health and Safety Executive, the Medicines and Healthcare Products Regulatory Agency, and the National Measurement and Regulation Office.
If it is discovered by market surveillance authorities that your product has not met CE marking requirements, you would typically have the chance to have the product CE marked correctly. If your product fails to comply after this opportunity to take remedial action, you would need to take the product off the market, could be liable for a fine, and may even risk imprisonment.
What’s the difference between EC and CE certificates?
The EC certificate is an EC Declaration of Conformity, which can be required to accompany products. This document is used to demonstrate that the product conforms to the relevant directives and standards, and includes details about the product and the manufacturer.
There are no ‘CE certificates’ as such. The certification required for CE marking is a Declaration of Conformity and Technical File.
What will happen to CE marking after Brexit?
After Brexit, CE marking will still be required for goods being sold in or supplied to the European market, including the relevant European Union (EU) and EEA member countries. The UK will continue to accept the CE mark for the majority of products until 1st January, 2022. After that, UKCA marking will be required for products, production tools and equipment being supplied or sold in Great Britain.
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