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EU-Authorised Representative

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EU-Authorised Representative

By Regulatory Globe

EU-Authorised Representative

By Regulatory Globe
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Who needs an EU-Authorised Representative:

For manufacturers who are not established in the Union, the EU Authorised Representative plays a pivotal role in ensuring the compliance of the devices produced by those manufacturers and in serving as their contact person established in the Union. (Medical Device Regulation 2017/745)

Why you should get in touch with an EU-Authorised Representative right now:

The situation is currently similar as it like is with the Notified Bodies. There are not many EU-Authorised Representatives out there and not all of them will support your need medical scope. Therefore, its definitely recommended starting right now to have enough time to find an EU-Authorised Representative which fits best for you as a manufacturer.

Why EUmediq GmbH:

EUmediq GmbH is a group of highly qualified experts with a focus on medical device-related topics. EUmediq offers services in EU-Authorised Representation, Postmarket Surveillance, Training, Auditing and Interim Management.

 

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