Machinery is in EU/EEA regulated by the machinery directive, often referred to as MD, which defines the basic safety requirements for machinery to be placed on the European market. As the first certification body in Norway, DNV has been designated as Notified Body according to the new Machinery Directive (2006/42/EC).
CE Marking is legal requirement for the manufacturer before placing machinery on the market or putting into service in the European Union (EU) and its member states.
CE Mark permits the free movement of Machinery within the European Economic Area (EEA) and ensures the machinery to comply with essential health and safety requirements spelled out in directives.
Scope of the directive:
Machinery directive applies to:
- Interchangeable equipment
- Safety components
- Lifting accessories
- Chains, ropes and webbing
- Removable mechanical transmission devices
- Partly completed machinery
As a responsible importer, Machinery manufacturers are often presented with the challenges of complying with the directive such as,
- Determining the compliance requirement of the product.
- Identifying the EHSR's applicable and the possibilities for fulfilling the requirement.
- Fulfilling the Technical construction file requirements and completing the instructions for safe usage of the machinery.
Complying with the Directive
Manufacturer has to take the full responsibility for complying with the directive.
For Machinery listed in Annex IV, Manufacturer must involve a notified body to perform conformity assessment through a type examination procedure or a full quality assurance including Annex VII A of the directive.
For Machinery not listed in Annex IV and not part of the exclusions mentioned in the directive, Manufacturer must perform internal assessment per Annex VIII of the directive.
For Partly Completed Machinery, manufacturer must prepare technical documents per Annex VII B for the directive and assembly instructions per Annex VI.
Essential Health and Safety Requirements (EHSR)
Machinery and safety components covered by the directive shall satisfy the essential health and safety requirements set out in Annex I of the directive. Annex I covers the following:
- General remarks with Principles of safety integration
- Control systems
- Protection against mechanical hazards
- Required characteristics of guards and protection devices
- Risks due to other hazards
- Information covers Instruction for Use
- Supplementary essential health and safety requirements for certain categories of machinery
- Supplementary essential health and safety requirements to offset hazards due to the mobility of machinery
- Supplementary essential health and safety requirements to offset hazards due to lifting operation
- Supplementary essential health and safety requirements for machinery intended for underground work
- Supplementary essential health and safety requirements for machinery presenting hazards due to lifting of persons
Technical Construction File (TCF)
TCF is the responsibility of the manufacturer and it is mandatory for all machinery. TCF must contain the following information,
- Declaration of Conformity
- General description of product
- Overall drawings including circuit diagrams
- Detail drawing and calculations
- Risk assessment
- Essential requirements
- List of standards applied
- Test reports, results of design calculations, examinations carried out, etc.
- User - and installation manuals
TCF shall be available with a notified body for at least 10 years following the date of manufacturer of the machinery. DNV GL has the capability to hold the TCF for the manufacturers and issue a retention certificate.
Why do you need DNV GL?
DNV GL can provide independent advice or assistance to manufacturers in fulfilling their obligation to this directive such as
- Analyzing and identifying the EHSR's applicable for the machinery with special assessment processes
- Provide multiple solutions for complying with EHSR's requirements
- Help customers in building their instructions in view of the directive requirements
- Choosing a cost-efficient route to compliance
- Carryout the conformity assessment of the machinery
- Perform checks, inspections and tests needed to assess the conformity of machinery
Our Advisory service is a good example of helping the customer to identify their needs to fulfill these requirements.
Notified Bodies are independent organizations appointed by the respective European Economic Area (EEA) national authorities, to undertake conformity assessment before a product is CE marked. Certificates issued by a Notified Body are valid for, and accepted by, all members states of the EU/EEA.
DNV GL has been appointed as Notified Body to carry out conformity assessment as specified in the Machinery Directive, on behalf of the EU.
Manufacturers of machinery from all parts of the world can thus benefit from DNV GL's worldwide network. Before sales, all DNV GL approved machinery with the CE marking shall be followed by the number 0434.
DNV GL is also a Notified/Competent Body for many other directives, e.g. the Pressure Equipment (PED), Explosive Atmospheres (ATEX), Electromagnetic Compatibility (ECM) and Low Voltage Directives (LVD).
Non-Compliance to this directive:
Authorities in charge of the control of products entering or placed on the EU market, discover that the machinery fails to comply with the relevant essential health and safety requirements, the machinery shall be consisdered as a serious risk to health and safety.
The scale of punishment starts with an immediate removal of the product from EU and may lead to imprisonment of the responsible stakeholders with heavy fines.
Advantages of getting together with DNV GL:
DNV GL's knowledge and experience in this field, with specialists present all around the world, can help customers with various Machinery safety assistance. This over 150 year old company can share the experiences gained in various fields and can provide solutions to complex issues of machinery manufacturers and their customer requirements.
DNV GL - Your Market Leader in managing global impact for a safe and sustainable future.