‘agent’ – Any natural or legal person established in the Union, who has received and accepted a written mandate from a manufacturer, located outside the Union, to, on behalf of the manufacturer, carry out certain acts in compliance with obligations imposed on him by this Regulation.
The agent must comply with the obligations established in article 11 of Regulation (EU) 2017/745, of April 5th.
The agent (authorised representative) shall perform the following tasks specified in the agreement between it and the manufacturer.
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Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
To launch a medical device in a country, medical devices must comply with the local country’s regulatory requirements. Let us be your trusted partner in bringing your medical devices to the Global market. Contact us today to learn more about how we can assist you in every step of the way.
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