Machinery Directive

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

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:

Machinery
Interchangeable equipment
Safety components
Lifting accessories
Chains, ropes and webbing
Removable mechanical transmission devices
Partly completed machinery

Manufacturers responsibility:

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
Maintenance
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 has the capability to hold the TCF for the manufacturers and issue a retention certificate.

Why do you need DNV?

DNV 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 Body

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 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's worldwide network. Before sales, all DNV approved machinery with the CE marking shall be followed by the number 2460.

DNV 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:

DNV'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 - Your Market Leader in managing global impact for a safe and sustainable future.