CE Mark FAQ
- Which European safety laws and standards apply to our machine?
- What is a Declaration of Conformity?
- Can we indicate our customer, our marketing rep or our distributor on our Declaration of Conformity?
- What is a Technical File?
- When must we provide the Technical File to the authorities?
- Where must our Technical File be located?
- What happens if we export equipment to the EU without complying to the Directives?
- A dozen safety standards apply to our equipment or product. How can we reduce the complexity, time and expenses related to their purchase, understanding and implementation?
Q: Which European safety laws and standards apply to our machine?
A: On a typical packaging machine at least three 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.
Q: What is a Declaration of Conformity?
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.
Q: Can we indicate our customer, our marketing rep or our distributor on our Declaration of Conformity?
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:
- That they agree in writing to accept this responsibility and to have their name and address on your Declaration of Conformity.
- To consider the confidential and proprietary nature of your technical information.
- That EU Representative or EU Contact will be around for at least ten years.
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.
Q: What is a Technical File?
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..
Q: When must we provide the Technical File to the authorities?
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.
Q:Where must our Technical File be located?
A: The Technical File can remain with the manufacturer in the United States and must be available for a period of ten years.
Q: What happens if we export equipment to the EU without complying to the Directives?
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.
Q: A dozen safety standards apply to our equipment or product. How can we reduce the complexity, time and expenses related to their purchase, understanding and implementation?
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.