FLYER | EU Authorized Representative, UK Responsible Person and US Agent

When manufacturers of medical devices operate outside certain regulatory regions, they must appoint an official representative to ensure compliance with local laws and regulations.

When manufacturers of medical devices operate outside certain regulatory regions, they must appoint an official representative to ensure compliance with local laws and regulations.

These representatives, such as the Authorised Representative in the EU, the UK Responsible Person in Great Britain, and the U.S. Agent in the United States, play a crucial role in facilitating market access and regulatory adherence.

Each regulatory framework outlines specific duties for these representatives to ensure compliance and safety—have a look at the brochure for more details!

If you require any further information, contact us at: [email protected]

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March 14, 2025
| By Asphalion

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