A: On a typical packaging machine at least 3 Directives apply: The Machinery Directive, the Low Voltage Directive and the Electromagnetic Compatibility (EMC) Directive. Depending on the intended use of the equipment (residential laboratory, industrial, etc.) different standards can apply within the same Directive. Additional Directives may apply depending on the equipment specifications and the environment in which it operates. ACC will determine for you all of requirements that apply to your equipment or product.

A: The Declaration of Conformity is a signed statement by the manufacturer that their equipment complies with all the relevant and applicable EU Directives and Safety Standards. This document is required by customs officials and to be provided to the end-user who will be operating the equipment.

A: When selecting a company who is going to be your EU Authorized Representative or your Authorized EU Contact to compile the Technical File, make sure:

For various reasons you may not want your customer, marketing rep or distributor to be contacted by the authorities and then to have them involved in compiling your Technical File.

Call ACC for your EU contact solutions needs.

A: Essentially the proof that your equipment complies with all of the requirements, and includes technical documentation (drawings, schematics…), risk assessment, third party reports, test results, operation and maintenance manuals, a copy of the Declaration of Conformity, etc..

A: Only the authorities in the EU can request to examine the Technical File. This typically happens when there is a doubt on the conformity of the machine or an accident has occurred.

A: The Technical File can remain with the manufacturer in the United States and must be available for a period of ten years.

A: Enforcement is carried out on a member state basis. Heavy fines and criminal penalties can be imposed on the manufacturer. Current and future products could be banned from the market.

A: In addition safety requirements and standards are subject to revisions, interpretations and only a portion of these may apply to your product. The best answer is to talk with an experienced CE compliance company such as ACC that will simplify the process for you.