What is the CE certification and why is it necessary?
The CE certification process allows manufacturers to declare their product compliant with all the health and safety requirements of the European Community Directives. With EU machinery occupying one-third of the world markets; 170,000 companies and 3.3 million employees, minimizing the accident by machinery is an essential policy of the EU. The CE mark is not a quality mark, it is a guarantee of the manufacturer that the product meets all of the requirements of relevant EU product safety law.
Whose responsibility is the CE certification?
CE marking is the responsibility of the person who places the product on the market or puts it into service, for the first time. The responsible party could be:
- The manufacturer (most cases)
- The manufacturer’s authorized representative
- The importers of non-CE marked products into Europe
- Any user in Europe who makes a product for personal use
- Those who substantially modify existing products on the market
What is the Machine Directive 2006/42/EC?
The CE Machinery Directive 2006/42/EU is a set of requirements and processes for the responsible party. When your machinery is in accordance with this set of requirements, the CE mark can be affixed and the machinery can be legally sold to the European market. The current Machine Directive (2006/42/EC) has seven categories of equipment within its scope:
- Machinery (i.e. an assembly of linked parts, where at least one moves and is powered for a specific application)
- Interchangeable equipment
- Safety components
- Lifting accessories
- Chains, ropes, and webbing (for lifting purposes)
- Removable mechanical transmissions devices
- Partly completed machinery
What are the manufacturer’s responsibilities in achieving CE certification?
Most equipment falls under a self-declaration route where the manufacturer undertakes 5 key tasks:
- Undertaking a risk assessment
- Demonstrating conformity to the Essential Health and Safety requirements of Annex I of the Machinery Directive, or against the requirements of applicable harmonized standards
- Compiling the technical documentation
- Drafting the EC Declaration of Conformity
- Affixing the CE mark
There are separate routes for ‘high risk’ equipment (which are items that are listed within Annex IV of the Directive) and for partly completed machinery. Following the completion of these tasks, the product is eligible for CE marking.
What support do manufacturers receive during the CE certification process?
Certification Experts is able to assist your company by bringing the knowledge in-house with complete certification, training, and consultancy services. Here are some examples:
- Risk assessments to EN/ISO 12100 with sophisticated software
- Harmonized Standards Assessments
- Safety review and Machine or component testing
- Engineering review and co-engineering
- Technical file compilation
What constitutes the process for CE certification?
CE marking is the final stage of the conformity assessment process as specified in the relevant Directive for the product. It is concerned with:
- Risk assessment of a product throughout its life-cycle
- Meeting safety objectives by design and construction
- Taking account of the current best practice to ensure the safety for that product aka the ‘state of the art’
- Collecting and retaining information about the design, testing, and construction process and how the product complies with the essential requirements of all relevant product safety Directives in a technical file for at least 10 years prior to production
- Declaring the product’s conformity with all relevant product safety law by means of a document the Declaration of Conformity
- Preparation of a comprehensive product user manual, in the language of the end-user
Risk assessment according to EN/ISO 12100
The international ISO 12100 standard for safety-related to machine and plant applications the way to conduct a thorough risk assessment of your machinery. This process shapes the foundation for the CE-marking process for Europe as well.
For this process Certification Experts uses a developed certified software program called Safexpert. It standardizes the process of performing the risk assessment and displays it in an efficient manner. Safexpert accelerates the safety documentation process and allows collaboration in one system. Besides the use we are also an official dealer of Safexpert in the Benelux.
Read more about Safexpert Risk Assessment Software over here..
What is the DoC?
The EC Declaration of Conformity also widely known as ‘’DoC’’ is a formal statement from the manufacturer that a machine complies with applicable directives and standards, signed by the responsible person within the organization or Authorized Representative.
The EC Declaration of Conformity for machinery must include:
- Business name and full address of the manufacturer and, where appropriate, his authorized representative
- Name and address of the person authorized to compile the technical file, who must be established in the Community
- Description and identification of the machinery, including generic denomination, function, model, type, serial number, and commercial name
- A sentence expressly declaring that the machinery fulfills all the relevant provisions of this Directive and where appropriate, a similar sentence declaring the conformity with other Directives and/or relevant provisions with which the machinery complies. These references must be those of the texts published in the Official Journal of the European Union
- Where appropriate, the name, address and identification number of the notified body which carried out the EC type-examination referred to in Annex IX of the MD and the number of the EC type-examination certificate
- Where appropriate, the name, address and identification number of the notified body which approved the full quality assurance system referred to in Annex X of the MD
- Where appropriate, a reference to the harmonized standards or other technical standards used
- The place, date, identity and signature of the person empowered to draw up the declaration on behalf of the manufacturer or his authorized representative
In which cases do manufacturers need an updated CE Certification?
The following enumeration outlines the different situations involving modifications to machinery where the requirements of the Machinery Directive may apply and action must be taken:
- Machinery is modified to the extent of being ‘new’ machinery
- Machinery is refurbished with a different safety package
- An existing assembly of machines is modified
- Machinery is modified before it is first put into service