What is a European Authorised Representative (EAR)?
A European Authorised Representative (EAR) is an entity located in the EU that acts on behalf of non-European medical device manufacturers to ensure compliance with EU regulations.
Who must appoint an authorised representative?
Any manufacturer of medical devices not based in the EU must appoint an EAR to sell its products in the EU Member States, in accordance with European regulations (MDR).
What are the main responsibilities of an authorised representative?
An EAR is responsible for ensuring that a manufacturer's medical devices comply with regulatory requirements, including product registration, communication with the authorities and management of post-market reports.
How does Medicina Legatis facilitate entry into the European market?
Medicina Legatis supports manufacturers throughout the process, from device registration to compliance with the EUDAMED database and management of post-marketing reports.
What types of medical devices are covered by Medicina Legatis?
We work with a wide range of medical devices, from diagnostic technologies to surgical equipment. We guarantee that all types of non-European medical devices comply with European standards.
Can Medicina Legatis manage communications with the European authorities for my company?
Yes, as your EAR, we handle all communications with the relevant authorities, ensuring optimum responsiveness and rigorous monitoring of your files.
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