Machinery Directive 2006/42/EC - self-approval or need for Notified Body?
All machines must be CE marked in accordance with the Machinery Directive before they can be marketed and put into use on the European market. The CE marking ensures the free movement of the product throughout the European Economic Area (EEA), and with the marking the manufacturer or importer guarantees that the product complies with all the legal requirements of that Directive.
In the vast majority of cases, you - as a manufacturer - can 'self-approve' your machines without the involvement of a third party - and you can issue a Declaration of Conformity for compliance with the directive. However, certain hazardous machinery may be subject to special conformity assessment procedures requiring EU type testing to be performed by a Notified Body.
These machines include:
- Lifts for persons or persons and goods
- Car lifts
- Circular saws
- Planer with manual feed for woodworking
- Thickness planer for woodworking
- Combined woodworking machines
- Milling machines with vertical spindle - with manual feed - for machining wood
- Presses - including edge presses - for cold working of metals
- Detachable mechanical transmission shafts, including their guards
- Shields for detachable mechanical power transmission devices
- Logical control units for safety functions
Annex IV of the Machinery Directive contains a complete list of these machines.
How can the Danish Technological Institute help you?
Certification & Inspection at the Danish Technological Institute is the only agency in Denmark designated as a Notified Body (number 0396) for type examination of machines covered by Annex IV of the Machinery Directive 2006/42/EC.
Certification & Inspection is designated by the Danish Safety Technology Authority and accredited by DANAK.
We have been working as a notified body within the Machinery Directive since 1995, so we have extensive experience with type approvals of dangerous machines.
When you choose us to carry out the type examination of your Annex IV machine, you also ensure that the communication takes place in Danish (or English, if you choose this) - and you receive a type test certificate with a stamp from the Danish Technological Institute and DANAK - a stamp that stands for quality and is well known in the EU.
The process for type examination typically starts with an initial dialogue, where the product is presented and where the practical process is agreed.
The type examination or certification basically consists of the following processes:
- The manufacturer submits an application with name, address, and information about production sites
- The manufacturer submits technical documentation
- The Danish Technological Institute examines and approves the technical documentation
- The Danish Technological Institute informs the manufacturer of the results of the examination
- Time, place and scope of testing and examination are agreed
- The Danish Technological Institute carries out inspection of the type, and carries out necessary practical tests and examinations in cooperation with the manufacturer
- The Danish Technological Institute issues the type examination certificate.
The technical documentation must as a minimum contain:
- A description of the machine
- Construction and fabrication drawings as well as sketches of components, sub-assemblies, electrical and hydraulic circuits, control/software, etc. and possibly descriptions and explanations necessary for understanding said drawings and sketches
- Construction calculations (strength calculations) and surveys etc.
- Data sheets, certificates etc. on used components
- List of standards that are wholly or partially used
- List of Essential Safety and Health Requirements that are not covered by the standards
- Risk assessment and documentation for compliance with the Machinery Directive and applied standards with a description of selected solutions
- Results of any test reports
- Instructions for use
- Declaration of conformity (presentation)
Contact us if you want help with the type examination, or if you have questions about the above.