Representative Services

Are you planning to conduct a Clinical Investigation Study in Europe or are you seeking to obtain or renew your CE- certification to sell your MD’s in Europe?

If your company does not have a physical location in Europe, according to EU 2017/745 MDR, you are required to appoint a Legal Representative and an Authorized Representative to represent your company towards the EU authorities.

Legal Representative according to Art. 60 EU 2017/745 MDR

What is the role of the LR?

The Legal Representative will be the liaison between you and the Competent Authorities and will be responsible for;

Ensure compliance in conducting of a Clinical Investigation Study.

Ensure that the regulatory submissions to the Competent Authorities and the Ethic Committees in compliance with EN ISO 14155 and the applicable European and international standards.

Ensure that safety reporting is done to all member states in which the clinical study is been conducted.

Coordinating and assisting with clinical site and sponsor inspections to comply with applicable European harmonized standards and relevant international standards including all national guidance documents.

Why choose TRIQ as your Legal Representative (LR)?

Your LR must, not only have the presence but must have extensive knowledge and experience with Medical Device Regulatory Affairs and the related communication with the relevant authorities.

Our experienced consultants will review your Clinical Investigation Study documents and files and respond to any questions or concerns from the Competent Authorities.

You will have secure online access to all your documentation and regulatory information, including language requirements, directives, guidelines, and more.

TRIQ informs it’s clients of any relevant critical regulatory updates in Europe.

Each project has it’s unique requirements, Contact TRIQ to get more information and find out where we can support your needs.

Questions and Answers

YES, EU 2017/745 MDR requires you to appoint a Legal Representative (LR) who will be the contact for the authorities on all matters concerning the Clinical Investigation Study.

No, only one LR may be appointed by the sponsor for any specific protocol.

Need More Information ?

If you have specific questions or want to know what TRIQ GROUP can do for you then please contact us.