EMC – Electromagnetic Compatibility Directive

Electric and electronic medical devices will have to fulfill the requirements laid down in the Electromagnetic Compatibility (EMC) Directive 2014/30/EU in addition to those described in the applicable medical devices Directives and Regulations.

EMC Compliance Process

  1. Appoint your European Authorized Representative
    → Ask for our quotation!
  2. Identify all EU Directives/Regulations applicable to your product (such as environmental regulations etc.)
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  3. Identify the applicable harmonized standards for your product 
    → We will provide a list!
  4. Prepare a Technical File (including User Manual)
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  5. Select a Notified Body to perform the required Conformity Assessment tasks
    → We will provide addresses!
  6. Prepare technical documentation in accordance with annex I 
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  7. Prepare your Declaration of Conformity
    → We will provide forms!