EU-AUTHORIZED-REPRESENTATIVE-AS-A-SERVICE

THE FORCE supports you in bringing your medical device to the European market and takes care of all related tasks of the representative.

Are you a manufacturer outside the EU and want to place your medical device on the EU market? If so, one of the prerequisites for you is to appoint an EU-authorized representative. We at THE FORCE are ready to take on this role: We help you to bring your product on the European market as well as to comply with all requirements of the MDR or IVDR to ensure safety and compliance throughout the life cycle of your device.

As your authorized representative, we:

...check that your EU declaration of conformity and your technical documentation have been drawn up and that an appropriate conformity assessment procedure has been carried out.
...verify that your device complies with requirements for the Unique Device Identification (UDI) and the EUDAMED registration.
...serve as your first contact for competent authorities and vice versa. For this purpose, we also keep available a copy of the technical documentation, the EU declaration of conformity, and the certificate for the appropriate period according to MDR/IVDR.
...cooperate with the competent authorities on your behalf on any requests, including preventive or corrective actions.
...immediately inform you about complaints and reports from healthcare professionals, patients, and users related to your device.

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