EMC – Electromagnetic Compatibility

Electric and electronic medical devices will have to fulfil the requirements laid down in the EMC Directive in addition to those described in the applicable medical device regulations.


1 Appoint your European Authorized Representative
Ask for our quotation!
2 Identify all EU Directives applicable to your product (such as environmental regulations, etc.) We will assist!
3 Identify the applicable harmonized standards for your product We will provide a list!
4 Prepare a Technical File (including User Manual) We will assist!
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 We will guide you through!
7 Prepare your Declaration of Conformity We will provide forms!

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