Procedures for Assessment of Conformity acc. to European Machinery Directive 2006/42/EC MD
By affixing the CE-Mark on a machine, its OEM asserts its complicance, on the day of hand-over, with all applicable European Directives and Regulations. Among these are, most notably:
For most machines, an OEM may do so under their own responsiblity.
Harmonized Standards must fully be adhered to for those dangerous machines contained in annex IV of machinery directive.
OEM have to compile a Technical File comprising among others, a description of the machine, its assembly drawing, operations instructions, and risk assessment.
The latter is best established right at the start of design.
OEM eventually assert meeting essential safety and health requirements of all applicable European directives and regulations. EC-Declaration of Conformity must be signed by a manager, who is authorised to represent the company. In most cases this is the CEO.
I have actively been involved in applying safety requirements of machinery directive since 1995. I deliver practial solutions for all safety issues. Do not hesitate to reach out to engineering consultant Wolfgang Grassberger, MBA for competent assistance in:
Under the European Machinery Directive 2006/42/EC – MD, any manufacturer may declare conformity of a machine with essential safety and health requirements of European Machinery Directive under their own responsibility. Harmonized standards must be applied to machines listed in Annex IV, or else those have to be type-examined by a notified body such as one of the four TÜV organizations.
By attaching the CE-Mark on a machine, it is marked by its manufacturer to comply with relevant essential safety and health requirements of all applicable European Directives and Regulations. Among these, Machinery Directive 2006/42/EC, Low Voltage Directive 2014/35/EC, and EMC-/Radio-Directive are the most common. For some, additional directives must be adhered to. Many machines may be assessed and checked on their manufacturer's own responsibility. A risk analysis is one of the required parts of the machine's technical file. It is much advisable to reach out to a competent engineering consultant such as an Austrian Ziviltechniker für Elektrotechnik.
Even when manufacturing a machine for one's own exclusive use, it must nevertheless be assessed and marked for conformity before being put into service (see European Machinery Directive 2006/42/EC – MD article 2 i) and article 5). Such machines for own use must comply with all relevant essential safety and health requriements put forth by annex I of MD. Among other documentation, operations instructions, risk assessment, EC-declaration of conformity, and the CE-mark are required. This also holds for lifting accessories.
An EC-Declaration of Conformity is always signed by the manufacturer. Endorsement from a notified body such as TÜV is mandatory only for those machines listed in annex IV of European Machinery Directive 2006/42/EC, if resp. machine has not been fully evaluated by adhering to Haromized Standards. Other applicable European Directives and Regulations may enforce additional procedures with the involvement of notified bodies, for e.g. pressure equipment.
A Declaration of Conformity applies to a machine only on the very day of handover from manufacturer to its user. Conformity can only be asserted for the condition in which machine is first brought on the market or put into service (see annex II of European Machinery Directive 2004/42/EC). Later modification is never covered by the original document. Substantial changes which introduce new, or enlarge exsting, risks, create a new machine, which warrants its own new Declaration of Conformity.