EU Registration Requirements

EU Registration Requirements for all Manufactures

EU registration requirements: In order to commercially market or distribute a product intended for use in the European union a verification that verifies that a device meets all regulatory standards/requirements of MDD or AIMD or MDR.

The steps towards getting EU registration: The first thing to do is determine which medical device directive applies to your device.  Then determine the classification, whether your device falls under Class I or Class IIa, Class IIb etc. All devices except the ones that fall under Class I should implement QMS. For devices from Class I to Class IIb a technical file should be prepared. Next step is to assign an Authorized Representative located in Europe. Except for Devices under Class I (Non-sterile) it is audited by a notified body and then CE marking is issued. A declaration of Conformity (DOC) is a requirement that is to be prepared by the manufacturer.

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