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.
Who We Serve
Trust our team of experts to handle the CE marking for you
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)
- Lifts
- Measuring instruments
- Noise emission in the environment
- Non-automatic weighing instruments
- Pyrotechnics
- 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)
- Machinery
- 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
- ATEX
- 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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Who We Serve
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.
| Role | Meaning | Obligation |
| Manufacturers | 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). |
| Importer | 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. |
| Distributor | 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. |
| End-user | 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.
Check out our services
Certification Experts carries out specific CE marking procedures for the following product categories:
Check below our subsidary services:
CE Marking
The 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.
- Conformity Assessement procedure
- Technical File
- Risk Assessment
- Inspection/Safety Assessment
- Testing
- Declaration of Conformity
- Authorised Representation
Route to Compliance / Classification
For 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.
- Determining how the applicable product legislation applies to your product
- Describing the steps of the conformity assessment procedure
- Determining roles and responsibilities of the parties involved
- Setting up test procedures
Engineering Review
Qualified 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.
- Design Review
- Pre-compliance testing
- Consultancy and assist in arranging the necessary product testing
GAP Analyses
A 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.
- Regulatory Framework Identification
- Current Practices Assessment
- Regulatory Requirements Evaluation
- Gap Identification
- Prioritisation
- Plan of Action
Risk Assessment
The 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.
- Execution of the risk assessment
- Guidance in performing a risk assessment
- Product testing and evaluation
- Training in risk assessment and use of Safexpert software
- Safexpert risk assessment software (TÜV certified)
Inspection/Safety Assessment
Certification 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.
- Perform onsite inspection/Safety Assessment
- Discuss pending queries
- Verify potential hazards and risks
- Review draft Risk Assessment
- Perform testing, based on the assumption all components are in compliance and the assembly will be tested when functioning as an integral whole
Technical File
A 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.
- Evaluating, guiding and providing instructions for use
- Evaluating, guiding and preparing Risk Assessment
- Assemble Technical File
- Drafting the Declaration of Conformity (DoC) template
- Review user information
Product Testing
Product 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:
- EMC (Electromagnetic Compatibility)
- Low Voltage / electrical safety
- RoHS
- Radio Equipment
- Medical
- Toys
- Machinery
- ATEX
- Safety
Authorised Representation
AR 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.
- EU Authorised Representative
- UK Authorised Representative
- EC Rep (Medical Devices)
- UK Repsonsible Person (UKRP)
- Responsible Person (RP) GDP
- Person Responsible for Regulatory Compliance (PRRC)
Training CE marking process
Certification Experts offers training programs that will prepare you for the CE marking process of your product.
- CE marking
- Safexpert software
Information and warnings for the end users
Certification Experts can provide help with the following to ensure that your manuals, labelling and packaging are fully compliant with your chosen markets.
- Checklists
- Product labelling
- Templates
- Drafting Manuals
- Machine plate
All the answers you might need!
It’s important to clarify a common misconception: the CE Certificate is distinct from a Declaration of Conformity. Although these documents are interconnected, they fulfill distinct roles within the framework of European Union (EU) product conformity. The CE certificate, typically issued by a Notified Body or accredited testing laboratory (though not obligatory for most products), is an official document verifying a product’s compliance with relevant EU regulations. On the other hand, the Declaration of Conformity is a mandatory self-declaration by the manufacturer for all CE-marked products. Both documents play crucial roles in affirming a product’s adherence to EU standards and eligibility for the CE marking, but they differ in their origins and functions within the broader conformity assessment process.
CE certificates are often issued by Notified Body or accredited testing laboratory, independent organisations designated by EU member states to assess product conformity. Therefore the best way to check the certificate is to contact the Notified Body or accredited testing laboratory to verify the certificate.
The manufacturer or Authorised Representative (AR) bears the responsibility for maintaining the accuracy and currency of information in the Declaration of Conformity (DoC). The contact details of the manufacturer or AR are explicitly stated on the DoC. These contact details serve as a direct means to reach out to the responsible party, allowing you to verify firsthand that the product aligns with the applicable European health and safety standards.
The CE mark indicates that your product is in compliance with the European product legislation. It is mandatory for all manufacturers whose products fall within the applicable CE directives and regulations to get CE certification before they can access the European market.
The CE mark, consisting of the letters “C” and “E” in a stylized circle, must be clearly visible on the product, packaging, or accompanying documentation.
The CE mark, which stands for “Conformité Européene,” signifies that a product complies with the essential requirements and standards set out in European Union (EU) directives or regulations. The mark indicates that the product has undergone the necessary conformity assessment procedures and can be legally placed on the market within the European Economic Area (EEA). The CE mark is not a quality or performance endorsement but rather a declaration of conformity with applicable EU requirements.
The costs for obtaining a CE mark vary and depend on factors such as product complexity, involvement of a Notified Body, consultancy, documentation, and testing. It is advisable to contact specialised organizations for an accurate estimate, and careful consideration of costs and benefits is crucial due to legal requirements and access to the European market.
The absence of required CE marking on a product, as mandated by applicable EU directives or regulations, can lead to severe consequences. These consequences include legal issues, fines, and other legal ramifications. The product may be prohibited from legal placement on the market in the European Economic Area (EEA). Additionally, customs authorities and market surveillance agencies in EEA countries may reject products lacking the appropriate CE marking, resulting in trade restrictions. The liability of the manufacturer may increase in case of accidents or damage caused by the product. Authorities may also demand the recall of non-compliant products from the market, incurring significant costs for the manufacturer. To avoid these risks, it is crucial for manufacturers to ensure that their products comply with relevant EU directives or regulations and undergo the necessary conformity assessment procedures before entering the EEA market. The proper application of the CE mark signifies adherence to applicable standards and safety regulations.
A Notified Body (NoBo) is an organisation that is designated by a European country to assess the conformity of certain products and devices, such as medical devices, before being placed on the market. Notified Bodies play a crucial role in the regulatory processes for various products, including medical devices, as well as other sectors such as machinery, personal protective equipment, and more. These bodies carry out tasks that are related to conformity assessment procedures set out in the applicable legislation when a third party is necessary.
Notified Bodies operate independently and are designated by EU member states’ competent authorities. The European Commission maintains a comprehensive list of Notified Bodies, and each Notified Body is assigned a unique identification number. The designation process involves demonstrating the competence and impartiality of the organization.
It’s important to note that the involvement of Notified Bodies is specific to certain regulatory frameworks, such as the Medical Device Regulation (MDR) in the EU. The specific requirements and procedures can vary based on the type of product and the applicable regulations.
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, testing, ensuring correct information and warnings, including CE label and compiling the Declaration of Conformity.
Please keep in mind that, for certain products, it is necessary to undergo a conformity assessment procedure with an accredited third party, such as a Notified Body or accredited testing laboratory.
The procedure for obtaining CE marking involves several steps, and it can vary depending on the type of product and the specific EU directives or regulations that apply. Here is a general overview of the process:
- Product Classification: Identify the applicable EU directives and/or regulations for your product.
Conformity Assesment Procedure: Conduct a conformity assessment to ensure compliance with essential requirements.
Notified Body: If required, involve a Notified Body for certain products.
Risk Assessment: Compyling a Risk assessment for identifying, evaluating, and mitigating potential hazards or uncertainties associated. - Technical Documentation: Prepare comprehensive technical documentation, including test reports and design drawings.
Declaration of Conformity: Create a Declaration of Conformity (DoC) to declare compliance.
CE Marking: Affix the CE mark visibly on the product, indicating conformity with essential requirements. - Authorised Representation: Non-EU companies have the option to designate an Authorised Representative to serve as an intermediary between their company and the relevant authorities.
Maintance: Maintain documentation for inspection purposes.
Not all products require CE marking. This marking, a regulatory conformity indicator, signifies that a product aligns with the essential requirements outlined in relevant European Union (EU) directives or regulations. The obligation for CE marking varies based on the product type and the specific EU directives or regulations applicable.
Products falling under the purview of specific EU directives or regulations must bear the CE mark to be lawfully introduced to the market within the European Economic Area (EEA). Product categories often requiring CE marking encompass machinery, electrical and electronic equipment, medical devices, toys, construction products, and personal protective equipment.
Conversely, products outside the scope of particular directives or regulations are not allowed to bear the CE mark. For instance, most food products, chemicals, cosmetics, and select consumer goods may not require CE marking.
It’s imperative for manufacturers to identify the specific regulations relevant to their products and assess the necessity of CE marking. If a product falls under the jurisdiction of a pertinent CE directive or regulation, manufacturers must undergo the requisite conformity assessment procedures and affix the CE mark before introducing the product to the EEA market.
The responsibility for CE marking lies with the manufacturer or part of the responsabilities with their Authorised Representative (if the manufacturer is based outside the EU). In some cases, for certain products, the involvement of a Notified Body (an independent organisation designated by an EU member state) may also be required.
Here are the key roles:
Manufacturer: The primary responsibility for CE marking rests with the manufacturer. They must ensure that the product complies with the relevant EU directives or regulations, conduct the necessary conformity assessment procedures, and affix the CE mark. The manufacturer is also responsible for preparing the technical documentation and the Declaration of Conformity.
Authorised Representative (if applicable): If the manufacturer is based outside the EU, they can appoint an Authorised Representative within the EU to act on their behalf. The Authorised Representative shares some responsibilities with the manufacturer, including maintaining the technical documentation and the Declaration of Conformity.
Notified Body (if required): For certain products, involvement with a Notified Body may be mandatory. The Notified Body is responsible for checking specific conformity assessment procedures, such as testing and inspection, to verify that the product meets the essential requirements. The Notified Body’s involvement is often required for high-risk products.
It’s crucial for the manufacturer to understand the specific requirements for their product category, identify the applicable EU directives or regulations, and determine whether the involvement of a Notified Body is necessary. Additionally, manufacturers must keep comprehensive records of the conformity assessment process, technical documentation, and the Declaration of Conformity. This documentation should be made available for inspection by authorities if requested.
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