Obtain your CE marking successfully
and bring your products safely onto the European market
Certification Experts is your full-service compliance partner and guides you through the complete CE marking process to obtain the Declaration of Conformity. With over 25 years of experience, our team will help you to obtain access to the European market.
Challenges of CE certification
Guidance from start to finish
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CE marking meaning
CE stands for the French abbreviation of Conformité Européenne (European Conformity). By affixing the CE marking to a product, a manufacturer declares that the product meets all the legal, safety, health and environmental protection requirements for CE marking and can be sold throughout the European Economic Area (EEA).
Who needs CE marking?
It is mandatory for all manufacturers and whose products fall within the applicable CE marking directives and CE marking regulations to get CE certification before they can access the European market. If an importer markets the product under its own name, it assumes the responsibilities of the manufacturer, and must apply the CE marking itself. Alternatively an Authorised Representative (AR) can be appointed.
CE marking is mandatory for manufacturers in the following product groups:
- Machinery (MD)
- Medical devices (MDR)
- Radio equipment (RED)
- Low voltage (LVD)
- Electromagnetic compatibility (EMC)
- Personal protective equipment (PPE)
- Pressure equipment (PED)
- Toy Safety (TSD)
- Construction products (CPR)
- Restriction of hazardous substances in electrical and electronic equipment (RoHS)
- Active implantable medical devices
- Appliances burning gaseous fuels
- Cableway installations designed to carry persons
- Ecodesign of energy related products
- Equipment and protective systems intended for use potentially explosive atmospheres (ATEX)
- Explosives for civil uses
- Hot water boilers
- In vitro diagnostic medical devices (IVDR)
- Measuring instruments
- Noise emission in the environment
- Non-automatic weighing instruments
- Recreational Craft
- Simple pressure vessels
How to get CE certification?
The process of the CE certification procedure is dependent on the product group. Generally, manufacturers can perform self certification. This entails compiling a technical file, performing a risk assessment, product testing, ensuring correct information, user manual and warnings, including CE label and compiling the Declaration of Conformity. However, a third-party, such as Certification Experts, is often chosen by the manufacturer as this process is often time consuming, requires a specific in depth know-how and test facilities that are not always present. Certification Experts specialises in CE marking for the following products:
- Electric and electrical equipment (EMC, LV, RED, RoHS)
- Medical devices (lower risk class I)
When you want to bring a high risk product onto the market, you need to execute a conformity assessment procedure with an accredited third-party for instance a Notified Body (NoBo). Certification Experts specialises in CE marking for the following products that need an accredited third-party to bring them onto the market:
- Medical devices
- Personal protective equipment
- Construction products
- Measuring instruments
- Pressure equipment
If you are located outside of the EU, and you want to bring your product onto the European market, you may need an Authorised Representative to act as a liaison between you and the competent national authorities. AR Experts (part of Certification Experts) can act as your Authorised Representative.
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Declaration of Conformity
An EU Declaration of Conformity (DoC) is a mandatory document that either the manufacturer or your Authorised Representative need to sign to declare that your products comply with the EU requirements. By signing the DoC you take full responsibility for your product’s compliance with the applicable EU law. There is a common misconception that a CE certificate and a DoC are the same. A DoC confirms that the products of a manufacturer are in compliance with the European legislation. The CE certificate is given by an accredited party and is only mandatory for products which have to go through a conformity assessment procedure that is assessed by this party.
The different roles within CE marking
The different roles within the union harmonisation legislation (CE Marking) are specified as economic operators. An ‘economic operator’ means the manufacturer, the Authorised Representative (AR), the importer, the distributor, the fulfilment service provider or any other natural or legal person who is subject to obligations in relation to the manufacturer of products, who makes them available on the market or puts them into service in accordance with the relevant Union harmonisation legislation. A product subject to the union harmonised legislation may be placed on the market only if there is a manufacturer, importer, AR, or fulfilment service provider established in the Union who is responsible for the tasks set out in Market Surveillance Regulation (EU) 2019/1020.
|Any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under its name or trademark.
|Must understand both the design and construction of the product and carry out the applicable conformity assessment or have it carried out, to be able to take the responsibility for the product being in compliance with all provisions of the relevant Union harmonisation legislation (CE Marking).
|Any natural or legal person established within the Union who places a product from a third country on the Union market.
|Has a key role to play in guaranteeing the compliance of imported products. Herein an importer must assure that the appropriate conformity assessment procedure has been carried out by the manufacturer and that the manufacturer has drawn up the technical documentation, affixed the relevant conformity marking (e.g. CE marking), fulfilled his traceability obligations and accompanied, where relevant, the product by the instructions and safety information in a language easily understood by consumers and other end-users, as determined by the Member State concerned.
|Authorised Representative (AR)
|Any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks with regard to the manufacturer’s obligations under the relevant Union harmonisation legislation or under the requirements of this Regulation.
|Keep the EU declaration of conformity and the technical documentation at the disposal of national surveillance authorities and cooperate with them at their request. Additionally, the AR provides a competent national authority with all the information and documentation necessary to demonstrate the conformity of a product, upon their request, and cooperates with them to eliminate the risks posed by products covered by their mandate.
|Fulfilment service provider
|Any natural or legal person offering, in the course of commercial activity, at least two of the following services: warehousing, packaging, addressing and dispatching, without having ownership of the products involved, excluding postal services as defined in point 1 of Article 2 of Directive 97/67/EC of the European Parliament and of the Council, parcel delivery services as defined in point 2 of Article 2 of Regulation (EU) 2018/644 of the European Parliament and of the Council, and any other postal services or freight transport services.
|If there is no other economic operator available, a fulfilment service provider established in the Union assures that the appropriate conformity assessment procedure has been carried out by the manufacturer and that the manufacturer has drawn up the technical documentation, affixed the relevant conformity marking (e.g. CE marking), fulfilled his traceability obligations and accompanied, where relevant, the product by the instructions and safety information in a language easily understood by consumers and other end-users, as determined by the Member State concerned.
|Any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market.
|The distributor must be able to identify the manufacturer, his Authorised Representative, the importer or the person who has provided him with the product in order to assist the market surveillance authority in its efforts to obtain the EU declaration of conformity and the necessary parts of the technical documentation.
|An end-user is a natural or legal person who is resident or based in the Union and who provides a product either as a consumer outside of their profession, or as a professional end-user for their industrial or professional activities.
|End-users are not subjected to the requirements of the Union.
General Product Safety
Products that do not fall within the scope of any CE marking directives and CE marking regulations must meet the requirements defined by the General Product Safety Directive 2001/95/EC or other legislation, such as the Cosmetic Products Regulation, Food Contact Materials Regulation, etc. Affixing a CE marking to these products is prohibited. Products that do not fall under the scope of needing a CE label must still meet the safety requirements of the general safety for products before they are placed on the European market and/or put into use.
According to the European Commission (EC), the General Product Safety Directive (GPSD) is outdated. Therefore, it has been proposed to reform the GPSD with a new regulation. The proposal for a new regulation focuses on the safety of products related to new technologies and on the challenges posed by the growth of online sales, ensuring more efficient and uniform market surveillance and improving the recall of dangerous products. If the proposal is adopted by the European Council and the European Parliament, it will replace the current GPSD.
CE MarkingThe CE mark serves as proof that a product complies with European product regulations. It’s a mandatory requirement for manufacturers whose products fall under applicable CE directives and regulations before they can enter the European market. Additionally, other parties like importers, distributors, and authorized representatives have their roles in ensuring that products bear the CE mark. Obtaining CE marking can be a complex and time-consuming endeavor. It involves understanding regulatory requirements, accessing the necessary testing facilities, and managing time effectively. Our team of CE mark consultants is here to support you throughout this process. We’ll guide you, conduct the required testing, and simplify the path to obtaining CE marking for your products. As your dedicated compliance partner, we aim to streamline this often intricate procedure.
Route to Compliance / ClassificationFor every market, Certification Experts can provide a practical compliance roadmap. This will ensure your access to any chosen market in the most time and cost-efficient way. This service can entail a classification of relevant Product Safety Regulations, an assessment of the product, an analyze of the design, a verification of the used components, materials and a determination of the potential risks associated with its use.
Engineering ReviewQualified engineers or experts of Certification Experts can carry out systematic examination of a product, system, process, design, or project, during the development phase. The purpose of an engineering review is to assess various aspects of the subject matter to ensure its functionality, safety, compliance with regulations, quality, and overall performance.
GAP AnalysesA GAP analysis based on product specific regulations is a structured assessment that identifies the differences or “gaps” between a company’s current practices and the requirements stipulated by product safety regulations. This type of analysis helps organizations ensure that their products are compliant with the relevant safety standards and regulations. Certification Experts can carry out a GAP analysis based on the specific requirements for organisations to ensure that their products meet safety standards and remain compliant with regulatory requirements. It helps mitigate risks, ensures consumer safety, and safeguards a company’s reputation in the marketplace.
Declaration of ConformityA Declaration of Conformity (DoC) is an official document in which the manufacturer declares that their product is in compliance with the essential requirements of the applicable European CE Directives and/or Regulations. Certification Experts has both the knowledge and international experience to help you draw up a suitable EU Declaration of Conformity for your product, thereby ensuring that your product is safe and will be able to enter the market.
Risk AssessmentThe European Product Legislation requires manufacturers to incorporate a risk assessment of potential risks associated with their equipment into their technical file. As stated in the directive an ‘adequate analysis and assessment of the risk(s)’ is required Certification Expert provides full guidance and execution of this requirement.
Inspection/Safety AssessmentCertification Experts offer to carry out inspections/safety assessments based on European Product Legislation (CE Marking) to guarantee that products meet the necessary safety and quality standards for sale within the European market. Non-compliance can result in significant legal consequences, including product recalls, fines, and reputational damage. Therefore, it’s crucial for manufacturers to have a thorough understanding of the relevant directives and regulations, and to adhere to them to ensure compliance for their products.
Technical FileA Technical File contains relevant information that should demonstrate that your product complies with the essential requirements as stated in the relevant directives and/or regulations. It is a mandatory component of demonstrating the conformity of your product. As your full-service compliance partner, Certification Experts can assist you in gathering all necessary information and preparing and composing the Technical File.
Product TestingProduct compliance often requires product testing, a requirement determined by applicable legislation. Certification Experts specializes in product testing, offering in-house, on-site, and partner test lab solutions. Our most common testing:
Authorised RepresentationAR Experts (part of Certification Experts) can act as an authorised representative on behalf of your organisation and ensures that the products being sold on the EU and/or UK market comply with the applicable product compliance legislations. This concerns products that are sold either directly, via e-commerce (online), or through a fulfilment service provider. We operate in various sectors, such as Machinery, Electronics, Medical Devices, Consumer Product, Toys, Personal Protective Equipment, Boats and more.
Training CE marking processCertification Experts offers training programs that will prepare you for the CE marking process of your product.
Information and warnings for the end usersCertification Experts can provide help with the following to ensure that your manuals, labelling and packaging are fully compliant with your chosen markets.
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