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.