According to the MDR regulation, if the clinical trial sponsor is not established in the Union, the sponsor shall designate their legal representative who shall be established in the Union.
As a sponsor’s representative, we provide services including:
- efficient communication between the Member State, trial site and the trial sponsor;
- substantive support in communication with authorities supervising the trial;
- support in reporting serious adverse reactions.
What are the responsibilities of the sponsor’s representative?
The representative’s responsibility is to ensure that the clinical trial sponsor properly fulfils their obligations. Such a representative is also responsible for communication with competent authorities and for the information exchange between member states, the investigator and the sponsor. Under MDR regulations, any information provided to the legal representative is considered as information provided to the sponsor.