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CE Marking for Machinery

Services according to the Machinery Directive 2006/42/EC

Our team of experts has over 25 years of experience and can help you achieve full CE machinery certification. This means that you will achieve the compliance you need to sell your machinery and installations the European market.

CE marking machinery

The CE mark for machinery indicates that your machinery is in compliance with the European product legislation. Without this marking, it remains unconfirmed that your product can be used safely and therefore cannot access the European market. Certification Experts can help you achieve full CE compliance so your machinery can enter the European market.

Challenges with machinery certification

Obtaining CE approval for machinery can be a complex process. This is because you, as a manufacturer, must confirm that your machinery meets the EU Machinery Directive 2006/42/EC. This 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. On top of that, there are many exclusions, such as audio and video equipment, which do not fall under the EU Machinery Directive 2006/42/EC but more specific directives.

Guidance from start to finish

Our experts can determine whether the EU Machinery Directive 2006/42/EC is applicable to your machinery, and then guide you through the process of identifying and reducing the potential risks to as low a level as possible. When doing so, we follow the requirements as they have been laid out in the safety standards. We will thus help you to get CE marking, so the compliance of your machine is confirmed, allowing you to access the European market.

Let our dedicated
team of experts handle the CE marking process for your machinery

CE 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.

How to get CE certification for machinery

In order to attain the CE mark for 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

The final step: your EC Declaration of Conformity

The final mandatory step is the signing of a Declaration of Conformity (DoC) for your machinery. An EC Declaration of Conformity is a document, drawn up by you (the manufacturer) or your Authorised Representative (AR) in which it is declared that a product is in compliance with all relevant European product safety requirements. Drafting the DoC is the final step of the CE marking process before you affix the CE mark to your product. It is either your responsibility or that of your AR to ensure that the information provided on the Declaration of Conformity is relevant and up to date. 

To dispose of a common misconception: the EC Declaration of Conformity is not the same as and cannot be replaced by a Declaration of Incorporation (DoI). A Declaration of Incorporation is a document that is used for partly completed machinery, which is designed to be incorporated into another product. These machines are thus supplied as components or sub-assemblies for other, bigger machines, meaning that they cannot be considered as CE-markable products. To ensure that these products are handled safely as well, the Declaration of Incorporation is the legal confirmation that these are unfinished products and cannot yet be considered as safe. Thus, the DoI does not and cannot replace the Declaration of Conformity. 

INSIGHT

What is a Declaration of Conformity?

INSIGHT

CE marking refurbished or modified machinery

INSIGHT

What types of testing does Certification Experts perform?

Certification Experts
offers the following services

Click on the service blocks below to see what our experts can do to help you achieve compliance for your machinery and installations. 

Compliance
Route to Compliance
Engineering Review
Risk Assessment
Inspection
Technical File
Information and Warnings For the End Users
Training
Authorised Representative (AR)
Expert Consulting

Get the right marking for your Machinery and Installations with our proven process

01 - Classifying

relevant standards, directives and regulations

02 – Executing

the conformity assessment procedure and Risk Assessment

03 – Inspection

based on the EHSRs

04 – Compiling

the Technical File

05 – Applying

the CE marking and signing the DoC

01 – Identify
the legal framework for your machine
02 – Determine
the route to compliance
03 – Perform
the conformity assessment procedure
04 – Marking
can be affixed and the certificate signed
05 – Ship
your product worry-free to the desired market
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What our clients are saying about us

Van Heek Medical
Wilma Peereboom
Quality Coordinator
The cooperation with CE goes satisfactorily. They were decisive from the start and things were well taken care of. I see the problem-solving capacity of Certification Experts as a strength of the company’.
6 weeks
Europe
Medical
Confocal
Peter Drent
CEO
Personally I am very satisfied with the service and quality of the work of Certification Experts. With future projects, I certainly intend to work with them again.
3 weeks
Europe
Electronics
Gallery Play Media
Ruben Kieftenbelt
Founder & CTO
The test results during the certification project were comprehensive and detailed. We experienced this as a pleasant and valuable result. In addition, Certification Experts swiftly came up with solutions for obstacles we encountered during the certification process.
4 weeks
Europe
Electronics
Adtrack Media
Paul East
CTO
We have found Certification Experts to be helpful, knowledgeable and prompt even during the difficult environment due to the COVID-19 pandemic. We look forward to working with Certification Experts on future projects.
4 weeks
Europe
Electronics
Nikon
Joachim Hofmann
GM Service & Support
We found the collaboration with the CE Team very helpful, professional, fast and flexible. It is always good to have a partner at hand who can help with profound expertise whenever required. In the future, CE will stay our choice if expert-know-how is needed.
4 weeks
Europe
Electronics
Physee
Wai-Man Tang
Quality Assurance Manager
We have a wonderful experience working with Certification Experts. We are a scale-up doing product developments under a very tight timeline. Certification Experts will adjust to our needs and guides us step by step to complete our product certifications in time.
3 weeks
Europe
Electronics
Oceanteam
Lars van ‘t Kruijs
Managing Director
The team of Certification Experts consists of nice people, it was a good cooperation! For me it was important how they made everything clear and how they thought along the same lines.
3 weeks
Europe
Machinery
Alfa Wasserman
Kurt Spiegel
Engineer Manager
CE has been our partner for over 10 years and the relationship is outstanding. The face-to-face meetings are really important and save us a lot of time.
6 weeks
Europe
Medical
Dot Robot
Edward Belderbos
Technical Director
It was a pleasure to work with Certification Experts. After reviewing our documentation, they gave us structured feedback and showed us a way forward to compliance with EU directives
3 weeks
Europe
Electronics
Noffz
Markus Solbach
Director Sales & Marketing
Certification Experts has a great service with high flexibility and really quick response time. We were impressed with their good technical understanding and detailed feedback to our complex test solution in a short timeframe.
4 weeks
North America
Electronics
Government of Canada
Melanie Ter Meulen
Trade Commissioner
The collaboration with Certification Experts runs smoothly and they are a valuable partner for us. If Dutch companies require specific technical information about the Comprehensive Economic & Trade Agreement on free trade, Certification Experts is the first to call.
2 weeks
Europe
Medical

Expert insights

Full-service product compliance without the headaches.

Leave it to us.

Compliance

Certifications Experts will help you enter the EU market with your machinery or installation. We offer complete certification guidance and expert services in order to ensure your machine is compliant with the CE marking legislation. 

  • Consultancy and advice on problem solving
  • Stipulate route to compliance
  • Determine the applicable standards, directives and regulations
  • Perform testing
  • On-site inspections
  • Design review
  • Technical file review
  • Preform risk assessment according to EN-ISO 12100:2010
  • Training
Route to Compliance

For every market, Certification Experts can provide a practical compliance roadmap. We offer guidance on cost and time efficiency regarding certification to be able to access multiple markets. 

  • Classification of relevant standards, directives, and regulations
  • Determining how the applicable product legislation applies to your machinery or installation
  • Selecting (harmonised) standards
  • Determining which b- and c-standards are usable for the overall risk assessment
  • Setting up test procedures
  • Describing the steps of the conformity assessment procedure
  • Determining roles and responsibilities of the parties involved. 
Engineering Review

Certification Experts can review your designs and assist you through the developmental phase to ensure that all critical safety standards are met. 

  • Design review
  • Co-engineering
  • Consultancy and advice on problem solving
  • Determining which b- and c-standards are usable for the overall risk assessment
  • Execution of Performance Level (PL) and calculations of Safety Integrity Level (SIL)
  • Performing risk assessment according to EN-ISO 12100:2010
Risk Assessment

Carrying out a risk assessment is required for all machinery. If you are unsure of how to carry out a risk assessment, Certification Experts can support you and provide full guidance.

  • ISO 12100:2010
  • Risk, Inventory and Evaluation (RI&E)
  • Verification and evaluation of existing risk assessment
  • Guidance in preparation of a risk assessment
  • Validation of safety functions
  • Execution of Performance Level (PL) and calculations of Safety Integrity Level (SIL)
  • Training in risk assessment and use of Safexpert software
  • Safexpert risk assessment software (TÜV certified)
Inspection

In order to check the mechanical compliance of your machine or installation, Certifcation Experts conducts inspections at your location. Based on the inspection, our experts will provide advice on the product compliance.

  • Conduct inspection on-site or digitally
  • Testing EMC and electrical safety
  • Checking overall machine safety
  • Inspection of essential health and safety requirements
  • Inspection of work environment
Technical File

In order to demonstrate the compliance of your machinery or installation, a technical file is required. Certification Experts reviews the documentation necessary for the technical file and guides you in composing it.  

  • Evaluating, guiding and providing instructions for use
  • Evaluating, guiding and preparing risk assessment
  • Assemble technical file
  • Assessing technical file
  • Drafting the EC Declaration of Conformity (DoC) template
  • Review user information
Information and Warnings For the End Users

To ensure that your product can be used safely, information and warnings must be provided for your end users. Certification Experts can aid in this proces.  

  • Provide machine plate template
  • Checking, guiding and/or drawing up instructions for use (manual)
  • Identification and verification of the warning signs
  • Drafting and evaluating safety instructions
Training

Certification Experts offers training programs concerning the CE marking of your machinery or installation. This provides you with the knowledge on how to enter your machinery or installation safely onto the EU market.  

  • CE marking
  • Machine and Robotics Safety
  • Safexpert software
  • Risk assessment
  • Machinery Directive (MD)
  • Work Equipment Directive
Authorised Representative (AR)

AR Experts (part of Certification Experts) offers Authorised Representative services for companies located outside of Europe and/or the UK.

  • Verifying the Declaration of Conformity, user manual, CE/UKCA logo and the technical documentation
  • Retainment of technical documentation and Declaration of Conformity at the disposal of qualified authorities
  • Provide all necessary information and documentation to said qualified authorities at their request
  • Immediate notification of the manufacturer in the event of complaints and reports
Expert Consulting

Certification Experts provides consultancy on every aspect of CE marking and machine safety. 

  • Machine safety
  • Product testing
  • Advice surrounding applicable product legislation
  • Contra expertise
  • Contact authorities
  • Legal support
Information Supply

We notify you if there are regulatory changes pertaining to your product

Risk Assessment

We help you eliminate risks more efficiently, protect your customers and your business. Unsure whether you’ve done something correctly? We can provide a full risk assessment evaluation.

  • Machine / Electronics / Toys / Medical / PPE / GPS
  • EN-ISO 12100
  • Safexpert Risk Assessment software (TÜV-certified)
  • Review of existing Risk Assessment
  • Templates
Authorised Representative

We provide Authorised Representation (AR) for businesses and e-commerce companies located outside the EU/UK – allowing access to those markets by registering us as your legal partner.

  • EU/UK market access
  • Verification of CE/UKCA
  • Marking
  • Contact point for authorities
  • Technical File
  • Bypass importers
  • Registration
Technical File

Every manufacturer requires a technical file to reach compliance. We support, compile and review these technical documents for you.

  • Declaration of Conformity
  • User Information (manual/labelling/packaging)
  • Risk Assessment
  • Technical schemes and drawings
  • Templates
Engineering Review

We review your designs and assist you through the prototype phase to ensure critical safety standards are met.

  • Design Review
  • Co-engineering
  • Consultancy
  • Risk Assessment
Testing and Inspection

Wherever you’re located, we offer a wide range of expert testing and inspection capabilities, both in house and via our global network of affiliated partners and testing laboratories.

  • EMC, Low Voltage, Radio, Medical, Toys, and PPE
  • On-site or digital inspections
  • Notified Bodies
  • Accredited testing laboratories
Route to compliance

We create a clear and practical compliance roadmap for you in any market. Get expert guidance on cost/time efficiency of certification for accessing multiple markets.

  • Determining product legislation
  • Set up test procedure (in-house/accredited testing)
  • Strategy on Global Market Access
  • Technical File Checklist
Training

We offer custom training programs led by experts, bringing your team up to
speed with important safety processes and regulations related to your markets.

  • Product Compliance
  • CE Marking
  • Machine / Robotics Safety
  • UL/CSA
  • Safexpert
User Information Review

Make sure your manuals, labelling and packaging are fully compliant with your
chosen markets. From writing to reviewing materials, we’ve got you covered.

  • Checklists
  • Product labelling
  • Templates
  • Drafting Manuals
  • Machine plate
Technical File

We ensure the availability of the technical file in case of requests from authorities

Expert Consulting

With over 25 years’ industry experience, our team can provide expert guidance
on every aspect of product compliance.

  • Product Compliance
  • Authority letter (NVWA, NoBo, ILT and BPT)
  • Authorised Representative
  • Product Testing
  • Seller/buyer problem resolution on CE marking
  • Advise on Product Legislation
  • User Information
  • Route to compliance
  • Engineering Review
  • Training
  • Risk Assessment
CE/UKCA Marking

Trust us as your partner to verify the compliance of your products

Authorised Representative

We register as your official point of contact for market surveillance authorities

EU/UK Market Access

You gain access to the EU/UK market, no matter where your business is located

Legal point of contact

We represent you on your behalf for all legal issues pertaining to your product

Compliance

Enter any market, no matter the marking or industry. From CE marking and UL to CCC, we offer complete certification guidance and expert services tailored to your unique situation.

  • Consultancy
  • Route to compliance
  • Testing
  • On-site inspections
  • Design Review
  • Technical File Review
  • Risk Assessment
  • Training