Legal Representative Services

 

The sponsor of a clinical investigation - who is not established in the EU - has to appoint a natural or legal person inside the EU as his 'Legal Representative'. As professional full service provider (with medical and clinical expertises in house) we're looking forward to act for you as 'Legal Representative' as defined in Article 50 of the MDR. Doing this we are responsible for ensuring your compliance with the obligations as defined in the new Medical Device Regulations (MDR). Any communication via the 'Legal Representative' shall be seen as communication with you as sponsor.

Please contact our office for more information: This email address is being protected from spambots. You need JavaScript enabled to view it.

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  • BREXIT impact
    How medical devices are currently regulated All medical devices are subject to EU legislation, which requires a manufacturer to place a CE mark on their product to attest compliance to applicable standards. Medical devices are regulated under Directive 90/385/EEC on active implantable medical devices (AIMDD), Directive 93/42/EEC on medical devices…

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