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
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|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!|