Update: From 14 January 2027, Directive 2006/42/EC is replaced by the new Machinery Regulation (EU) 2023/1230. Manufacturers are advised to prepare for the new requirements in good time.

CE Mark for Machinery 2006/42/EC

In accordance with the EU directives, the manufacturer of any machine intended for the European Union market must create and maintain, within the European Union, a Technical File for their product.

The Technical File of the machine must be structured in accordance with the requirements of the Machinery Directive 2006/42/EC and must contain information on its design, construction and mode of operation, so as to demonstrate its conformity with the relevant requirements, as set out in the harmonised standards and specifications applied.

Drawing up the Technical File is mandatory for two reasons:

• The information contained can be used by the Market Surveillance Authorities to verify compliance with the requirements
• The the manufacturer of the product uses the Technical File to demonstrate the conformity of their product with the applicable EU Directives

In the event that the machine is classified in Annex IX of the Directive due to high risk (e.g. band saw), certification of the machine by a Notified Body is required. In any other case, the Manufacturer, having developed a Technical File and drawn up a Declaration of Conformity, affixes the CE marking under their own responsibility (self-declaration).

The NOVITAS can effectively and correctly assist you

• With the classification of the machine
• In identification of the applicable harmonised standards
• With the performance of the machine's Risk Assessment
• With the development of the Technical File and
• With the and drafting of the Declaration of Conformity for your product.