Knowledge Base FAQs – CE Marking
- What is CE Marking?
CE marking is a certification mark that must be legally affixed to all products that fall under the scope of the European New Approach Directives. CE stands for Conformité EuropéenneEuropéenné. With this mark, the manufacturer, authorised representative, or importer (for products imported from outside the European Union) indicates that the product meets the legal requirements described in the applicable directive(s).
- How do I know if my product requires CE Marking?
The vast majority of products sold in Europe must meet the CE product safety requirements. To demonstrate that a product is safe for the user, CE marking is required. This indicates that the product has been tested, legal requirements have been met and the product is deemed safe to be sold on the European market. More information on which products must bear the CE mark can be found here. If CE marking doesn’t apply to a product, products can be subject to the General Product Safety Directive. There are also guidelines and regulations for specific product categories which are not included in the CE marking (e.g. cosmetic products).
- Who can apply CE marking for me?
This varies with each product. For a large number of products with a low safety risk, the manufacturer can determine whether the product meets the essential requirements outlined in the relevant Directive. Products with a higher risk should be tested and verified by an external examination institution.
- What happens if my product is brought into the market without CE marking?
If a product is unlawfully affixed with CE marking, the government of the specific member state can enforce legal measures. Products can be withdrawn from the market and penalties imposed. Manufacturers, Authorised Representatives, and/or importers will be held liable if the marking is fixed illegally or if the product doesn’t meet the correct standards.
- Which countries belong to the European Economic Area (EEA)?
The following countries are part of the European Economic Area (EEA):
- The Netherlands
- Czech Republic
Knowledge Base FAQs – Standards
- What are standards?
Standards are created by experts in the different member states who are connected to the CEN. They indicate the procedures that must be followed during the certification process so that when the standards have been met the products concerned are in compliance with the European Directives. The EN standards are recognised in all the different member states of Europe. Most standards are prepared at the request of the industry. The European Commission can also request the relevant standards bodies to prepare standards in order to implement European legislation.
Standards are voluntary, consensus-based, and as such does not impose any regulations. Contrary to the Directives, which are legal obligations. The European Commission establishes essential safety and health requirements (legal) in a Directive. European standards (EN) provide the test specifications and test methods (interoperability, safety, quality, etc.).
European Harmonized Standards (official abbreviation: hEN) are used to provide a presumption of conformity to Essential Requirements of the Directives.
- How many standards are there?
There are thousands of European Standards (ENs), all of which can be found on the website of the European Committee for Standardisation. Here you can search for more than 60000 documents, including extensive search functions (for each field, function, or subject) to find the right standard.
- Where can I find standards?
You can find standards on the website of the European Committee for Standardisation (CEN). The CEN is connected to technical institutions and develops and implements European standards for products to be traded on the European market. This includes construction products, machines, toys, consumer products, electrical products, and more.
- Which standards should cover my product?
To be able to make a preselection of standards with regard to the CE Marking, it is important to first determine which Directive(s) apply to your product. Once this has been determined, you can consult a list of harmonised standards to find the correct standard for your product.
You also have to determine which essential requirements apply to your product. Once this has been determined, you can use the accompanying harmonised standard(s) to cover the concerning requirement.
- How is it determined which standards should cover my product?
To be able to make a preselection of (CE) standards with regard to the CE Marking, it is important to first determine the product’s intended use and which Directive(s) apply to this product. Once this has been determined, you can consult a list with harmonised (CE) standards to find the correct standard for your product.
Knowledge Base FAQs – UKCA
- What is UKCA marking?
Since 1 January 2021, due to Brexit regulations, UKCA marking has been introduced as a requirement of all products being placed on the UK market. This framework replaces the European CE marking that was applicable to products whe
n the United Kingdom was still a part of the European Union.
This product certification requirement is applicable to all products entering England, Scotland, and Wales, while Northern Ireland will continue to accept CE marking or UKNI marking as certification for its territory.
- When is UKCA marking required?
Any product that was already on the UK market prior to 1 January 2021 is still able to bear the CE marking. There is also a one-year grace period for most products entering the UK market from Europe however the conformity assessment must be carried out by a UK recognised body. The grace period does not apply to products if the third-party conformity assessment was carried out by an EU recognised body.
- To which products does the UKCA marking apply?
The UKCA marking applies to most goods previously subject to the CE marking. Most manufactured goods require UKCA marking if they are being placed on the UK market. These include:
- Construction Products
- Radio equipment
- Personal protective equipment (PPE)
- Gas appliances
- Medical devices
- Which countries require UKCA Marking?
UKCA Marking product certification requirement is applicable for all products entering the UK market meaning England, Scotland, and Wales. Northern Ireland will continue to accept CE Marking.
- Can I apply both the UKCA and CE mark to my product?
Products may bear both the UKCA and the CE mark as long as they are compliant with both UK and EU regulations. Currently, the requirements for new approach goods are the same in the UK and the EU. Please bear in mind, however, that if EU regulatory changes occur which are not adopted by the UKCA framework, you will no longer be able to use the CE marking in the UK.
- Will UKCA marking be recognized in the EU?
UKCA marking will not be recognised on the EU market. Products currently requiring a CE marking will continue to require a CE marking for trade in the European Union. To continue selling products in the EU, producers who are based in the UK will need an authorised representative to do so.
Knowledge Base FAQs – Authorised Representative
- Why is it necessary to have an Authorised Representative?
A manufacturer can be based anywhere, but they must have a representative based in the European Union to sell their products in Europe. An Authorised Representative does the following on behalf of the manufacturer:
- Verifies CE marking
- Registers as the EU point of contact
- Ensures the availability of technical files
- Cooperates with authorities
- What does an Authorised Representative do?
An Authorised Representative (AR) verifies that your product is legally allowed to bear the CE mark by checking the technical file of a product, including:
- CE test reports
- Instructions for use
- Design documents
- Declaration (CE certificate) of Conformity
After evaluating the certification procedures and confirming the safety of a product, the Authorised Representative registers as the official EU point of contact. The AR acts as a liaison between the non-EU manufacturer and the European national authorities. The address and contact information of the AR must be provided on the product and its packaging.
As the EU point of contact, the Authorised Representative has several important responsibilities on behalf of the manufacturer. These include:
- Ensuring the availability of technical documentation
- Cooperating with market surveillance authorities
- Informing authorities when there is reason to believe that a product presents a risk
- Do I need an Authorised Representative?
If your business is based outside of the European Union, you need an Authorised Representative (AR) to verify that your product is legally allowed to bear the CE mark. AR services are mandatory if you plan to trade your product in the EU either directly, online (e-commerce), or through a fulfillment service provider.
- How do I choose an Authorised Representative?
It is important to choose your Authorised Representative wisely. Your AR will have access to all files and information of the concerned products, so appointing a party that is commercially or economically involved in the product area is typically how a manufacturer will select one. The AR should have expertise in compliance, given that the duties of the AR are aligned heavily with legislation and authorities. For example, verification of the Declaration of Conformity is a crucial step to ensuring your products are compliant, so ensuring this is done correctly and in line with legislative requirements will prevent legal complications in the future.
Knowledge Base FAQs – Declaration of Conformity
- What is a Declaration of Conformity?
The Declaration of Conformity is an essential required document of the European Product Directives for CE Marking. Once the CE mark is affixed to a product and the certification is complete, it must be supported by an official Declaration of Conformity (also known as DoC) in which the manufacturer declares that the product concerned complies with the essential requirements of the applicable European Directives. The CE marking must be affixed in a manner that is legible and cannot be removed easily from the product concerned.
You can obtain the CE mark and Declaration of Conformity by following these steps:
- Identify the EU requirements for your product
- Check whether your product meets the specific requirements
- Check whether your product must be tested by a Notified Body
- Test your product
- Compile the technical dossier
- Affix the CE marking and draft a declaration of conformity
Every product that is intended for use within the EEA (European Economic Area) and falls under one or more of the New Approach Directives must bear the CE marking and have a Declaration of Conformity.
- Why is a Declaration of Conformity required?
A Declaration of Conformity is a requirement for CE marking because it indicates that a product is verified for safe usage. When a manufacturer signs a Declaration of Conformity, they declare that the product has been designed and constructed with the appropriate conformity assessment requirements and take full responsibility for its compliance with EU health and safety standards.
A Declaration of Conformity must accompany all CE-marked products sold or traded in the European Union. This includes (but is not limited to) the following product groups:
- Machines and installations
- Electrical equipment and components
- Construction products
- Medical Devices
- Personal Protective Equipment
- Pressure Equipment
- Radio Equipment
It is an official declaration by the manufacturer or their representative that the product concerned is compliant with all relevant requirements of the European product safety directives. The Declaration of Conformity must contain all relevant product information, such as:
- Name/address of the manufacturer or a responsible authorised representative
- Description of product and model number
- Directives used for the CE marking certification
- List of standards used
- Name and position of the authorised representative
- Signature and date
- How long is a Declaration of Conformity valid?
After you have determined that your product meets all essential safety requirements, signed the Declaration of Conformity, and affixed the CE marking to your product, the EC Declaration of Conformity is valid for an indefinite amount of time. It remains valid for the product so long as no major product changes are made, for example:
- Change of original operation
- Change of original intended use
- Change of type
- Use of other components
- Use of new suppliers
In such cases, your product is considered a new product, and a re-evaluation certification process must take place (possibly on the basis of the previous certification). A proposal for a new EC Declaration of Conformity, in accordance with new guidelines and/or standards, should then be developed. The EC Declaration of Conformity must be kept at least ten years after the last date of manufacture of the product unless the directive expressly indicates another term.
- What does the number on the Declaration of Conformity mean and does it prove authenticity?
No. The authenticity of the Declaration of Conformity can only be ensured by the responsible party (the manufacturer or their authorised representative). The contact information of the responsible party is indicated on the DoC and you can use this information to contact them directly.
In most cases, the number on the Declaration of Conformity refers to the identification number of the Notified Body that performed the conformity assessment. You can use this number to search for the Notified Body on the NANDO website. On this site, you can also find an up-to-date list of all Notified Bodies per country and/or Directive.
- Can I draft the Declaration of Conformity myself?
If you are the manufacturer of a product, or if you sell the product under your own trademark onto the EU market, then you can draft the Declaration of Conformity yourself. Since it is your responsibility to ensure that your product complies with all relevant safety standards, we recommend that you seek legal advice if any ambiguities arise when drafting the Declaration of Conformity.
We hope this FAQ summary serves you well and helps with your understanding of product compliance requirements. Remember, our Knowledge Base is one of our main assets to our customers for providing clear and concise information relating to international product compliance. Keep an eye out for upcoming updates and improvements in the coming weeks.
If you have any questions on the above topics or would like some advice from us on product compliance, get in touch today.