Step-by-step plan for CE marking

We still receive many questions about CE marking and where to start. Below is a brief summary of how best to approach this.

Go to downloads for Declarations of Conformity in WORD

And in All about CE marking you will find answers to most CE questions.

For CE marking, you essentially always follow these steps:

  1. Determine which Directives/Regulations are applicable.
  2. Filter out the requirements regarding documentation, safety requirements, instruction manual, Declaration, but also what needs to be on the type plate, etc.
  3. Ensure the product complies with these (point 2).
  4. Assess whether the product meets these requirements. The risk analysis is always an important part of this.
  5. Prepare the technical file.
  6. Prepare the declaration of conformity.
  7. Apply the CE plate (what needs to be on it depends on the applicable Directive/Regulation).
  8. Prepare the instruction manual.
  9. And place it on the market and ensure aftercare.

Schematically, it looks like this:

 

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Philip Warneke and Dr. Richard Winter