In Switzerland, all companies producing machines for the Swiss market and the European Single Market are affected by the Machinery Directive 2006/42/EC (and the Swiss Ordinance on Machine Safety). A machine covered by the scope of this Directive may only be placed on the market if it meets the essential safety and health requirements.
The conformity assessment procedure
The risk assessment is the first step in the conformity assessment procedure. The risks for all phases of a machine’s life cycle must be identified, assessed and minimised using appropriate technical measures. The life cycle phases of a machine include its assembly, commissioning, operation, maintenance, dismantling and disposal. Any remaining residual risks must be included in the operating manual in the form of safety information and/or indicated on the machine itself.
The Machinery Directive distinguishes between machinery and partly completed machinery.
Components and parts such as hydraulic cylinders, mechanical transmission systems and bearings are not machines within the meaning of the Machinery Directive and can only be placed on the market following a declaration of incorporation. A machine that will be subsequently assembled using these parts and is functional must then undergo the full conformity assessment procedure.
CE marking is then carried out and the conformity declaration is issued. The requirements of the Machinery Directive are thus fulfilled and the machine can be placed on the market. A notified body must be involved in the conformity assessment for all the machines and safety components listed in Annex IV of the Machinery Directive.