Machinery and Installations
CE Marking services for Machinery
With over 25 years of expertise, our team guides you through the complete CE machinery certification process according to the Machinery Directive 2006/42/EC and Machinery Regulation (EU) 2023/1230. This ensures your machinery and installations meet the necessary compliance standards for CE marking, allowing you to confidently sell onto the European market.
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CE certification machinery directive
A Conformité Européenne (CE) marking is a regulatory standard that verifies that products are safe for use and sale in the European Economic Area (EEA). The Machinery Directive 2006/42/EC is the directive that applies to machinery, lifting accessories such as slings and chains, and safety components. You can find all details on what is defined as machinery in Article 2 of the official Directive. This directive can be divided in different sections, among which two of the most prominent ones: the essential health and safety requirements (EHSRs) and administrative provisions.
The EHSRs is essentially the list of requirements your product needs to meet in order to obtain the correct product marking. The administrative provision part states that manufacturers need to get their products marked, must produce a technical file, and sign a Declaration of Conformity (DoC). Our team here at Certification Experts can help you achieve all of these requirements and support you in the full process of getting your machinery CE marked.
Who needs CE certification for machinery
The EU Machinery Directive 2006/42/EC applies to all products that are considered machinery or safety components. You can find the details on what is considered machinery Article 2 of the official Directive. This definition encompasses a very large range of products and includes equipment that you, as a manufacturer, might be using yourself. If you thus want to enter the European market, your machinery and installations must bear the CE mark for machinery.
Under the CE marking system, manufacturers have the responsibility for CE marking. As a result, the manufacturer must draw up the Declaration of Conformity (DoC) and take responsibility for attaching the CE mark to the product. Other economic operators such as an Importer, Authorised Representative (AR), Fulfilment service provider and Distributor, also have a responsibility to ensure that the CE marking is implemented correctly by the manufacturer.
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How to get CE certification for machinery
In order to attain the CE marking machinery, companies must ensure that their machinery is compliant with all applicable European directives and/or regulations and have the required technical documentation. This must be done in order to be able to enter the European market. The Machinery Directive also requires that a manual must be provided in an approved language for the country of sale. Additionally, all machinery requires an EC Declaration of Conformity (DoC).
European Union member states cannot restrict the market placement of products affixed with the CE marking without adequate evidence of non-compliance. Certification Experts offers guidance on cost and time efficiency regarding the process of machinery certification. We will take care of the following steps for you:
- Classification of relevant directives and regulations
- Selecting (harmonised) ce standards for machinery
- Describing the steps of the conformity assessment procedure
- Determining roles and responsibilities of the parties involved
- Risk assessment & Risk reduction
- Inspection based on Essential Health and Safety Requirements (EHSR)
- Assemble Technical File
- Provide information for machine plate
- Compile EC Declaration of Conformity (DoC)
For control systems, additional functional safety requirements need to be taken into account:
- Performance Level (PL) EN ISO 13849-1/2
- Safety Integrity Level (SIL) EN IEC 62061
CE marking for machinery by Certification Experts
Certification Experts has a team of experts with both knowledge and experience to carry out the conformity assessment procedure based on the current Machinery Directive 2006/42/EC, so your company can affix the CE marking. In the near future, our experts will also be able to be of service regarding the new machinery regulation. Furthermore, our experts can carry out the required; classification, Risk Assessment, inspection based on Essential Health and Safety Requirements (EHSR), compiling of the Technical File, check of the users information (labelling, packaging, manual, machine plate) and compiling of the EC Declaration of Conformity (DoC). Furthermore, Certification Experts can provide several CE marking Machinery Directive training programs and conduct the Performance Level (PL) EN ISO 13849-1/2 and Safety Integrity Level (SIL) EN IEC 6206. Get your free quote here.
Certification Experts offer a range of services beyond CE marking for machinery. Some of the services they might provide include:
Check out our services
Discover how our experts can assist you in achieving compliance for your machinery and installations.
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
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
Declaration of Conformity
A 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.
- Determine specific declaration of conformity requirements
- Collect all necessary product information
- Determine applicable directives and legislation
- Draw up the Declaration of Conformity
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
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
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 Machinery
Certification Experts provides training for CE marking your machinery or installation, ensuring safe entry into the EU market.
- CE marking
- Machinery Directive (MD) and Machine Safety
- Functional safety (PL & SIL) for machinery
- Machine Safety Specialist with TÜV certificate
- Safexpert software
- Risk assessment
- Work Equipment Directive
Functional Safety
Functional safety services play a critical role in minimizing risks associated with complex systems, particularly those involving human safety. They ensure that products and systems operate reliably, even in the presence of faults or failures, by employing a combination of engineering techniques, thorough testing, and adherence to safety standards. Certification Experts provides guidance, evaluation, training, and certification services to ensure that your control systems comply with the required safety standards according to EN-ISO 13849 and the Performance Level concept.
- Calculations
- Expert guidance and advice
- Evaluation of safety functions
- Training
Performance Level (PL)
Performance Level (PL) services involve assessing and ensuring the safety of systems by determining and achieving specific risk reduction levels defined by safety standards. These services cover risk assessment, design, analysis, testing, and certification to meet required performance levels. Certification Experts can assist companies in implementing and meeting these requirements according to the EN-ISO 13849 standard.
- PL assessment and determination: Advice and implementation
Safety Intergrity Level (SIL)
Safety Integrity Level (SIL) is a concept used in functional safety standards like IEC 61508 and IEC 61511 to indicate the effectiveness of safety functions in reducing the risk of hazardous events. Certification Experts can support companies in implementing and complying with the Safety Integrity Level (SIL) standards, which are used for assessing and ensuring the safety of instrumental systems used in process industries. Our services involve activities aimed at assessing, designing, and verifying safety functions to meet the specified SIL requirements:
- SIL assessment
- SIL verification
- SIL management and advice
Lockout-Tagout-Tryout (LOTOTO)
LOTOTO ensures compliance with safety standards and prevents accidents. Certification Experts can assist companies in implementing and complying with the Lockout-Tagout (LOTO) process, also known as Lockout-Tagout-Tryout (LOTOTO). Our focus is on safe equipment maintenance and our services involve clear procedures, using locks and tags to prevent accidental activation, documenting steps, training workers, and verifying isolation. Herein, we will conduct a baseline assessment regarding LOTOTO
- Development of LOTOTO policies.
Working Equipment Directive
Working Equipment Directive Services help businesses comply with EU regulations for machinery and equipment safety. These services include risk assessment, safety measures, training, maintenance, and documentation to ensure a safe workplace and legal compliance. Certification Experts will ensure Workplace Equipment compliance as we specialise in helping businesses meet the requirements of this directive, ensuring the safety of your workplace equipment.
- Initial Assessment
- Regulatory Analysis
- Documentation Review
- Risk Evaluation
- Testing and Inspection
- Training
Machine Safety EN ISO 12100:2010
Learn about the NEN EN ISO 12100:2010, a European standard ensuring machinery safety by regulating the design process. Discover the principles of risk assessment, risk reduction, and the necessary steps for compliance to safely market machines within the EU. Get expert guidance for implementing ISO 12100 effectively.
Functional Safety
Functional safety services play a critical role in minimizing risks associated with complex systems, particularly those involving human safety. They ensure that products and systems operate reliably, even in the presence of faults or failures, by employing a combination of engineering techniques, thorough testing, and adherence to safety standards. Certification Experts provides guidance, evaluation, training, and certification services to ensure that your control systems comply with the required safety standards according to EN-ISO 13849 and the Performance Level concept.- Calculations
- Expert guidance and advice
- Evaluation of safety functions
- Training
Machine Safety EN ISO 12100:2010
Learn about the NEN EN ISO 12100:2010, a European standard ensuring machinery safety by regulating the design process. Discover the principles of risk assessment, risk reduction, and the necessary steps for compliance to safely market machines within the EU. Get expert guidance for implementing ISO 12100 effectively.All the answers you might need!
Most machinery falls within the scope of the EU Machinery Directive 2006/42/EC and if the machinery needs to enter the EU market, these need to be CE marked.
This directive applies to all products that are considered a machinery, interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, removable mechanical transmission devices and partly completed machinery.
The specific machines falling under the CE marking can vary depending on the nature of the equipment and its application. It is important for manufacturers to consult the relevant directives and standards to ensure their specific machines meet the requirements. When the product is classified as a product under the Machinery Directive, without the CE marking, it remains unconfirmed that the product can be used safely and, in such a case, cannot access the European market.
In essence, the UK government and civil services currently prioritize other matters over amending the UK’s Supply of Machinery (Safety) Regulations. Key considerations include potential trade agreements with the EU, mutual recognition agreements for certification bodies, and a comprehensive review of product safety legislation. The UK is likely to wait until the Machinery Regulation is published in the Official Journal before taking any significant action. In the short term, the CE marking will likely remain a valid alternative to the UKCA Mark. The UK is expected to transpose the Regulation into a UK statutory instrument rather than adopting it into domestic law. While there may not be exact regulatory alignment between the UK and the EU, commonality in Essential Health and Safety Requirements (EHSRs) is anticipated. However, administrative provisions, especially the requirement for a Notified Body in Annex 1, may not become part of UK law. This strategic decision may allow the UK government to assert that Brexit has reduced costs for machinery manufacturers, disregarding the increased expenses for those intending to sell Annex 1 machinery in the EU.
A Conformité Européenne (CE) marking is a regulatory standard that verifies that products are safe for use and sale in the European Economic Area (EEA). The CE mark for machinery thus indicates that your machinery or installations are in compliance with the European product legislation. Without this marking, it remains unconfirmed that your product is safe and therefore cannot access the European market.
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 Machinery Directive 2006/42/EC is the directive that applies to machinery, lifting accessories such as slings and chains, and safety components. As a manufacturer, you must confirm that your machinery meets this directive. This is done by obtaining CE marking for your machinery. If you do not obtain this marking, you cannot enter the European market with your products. The directive lists all the essential health and safety requirements that must be met and demands that machinery suppliers should identify the hazards their equipment might contain, to then assess the risks they could pose to the users.
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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