A2a. Authorisation from the sponsor
If the submitting party is not the sponsor, you must enclose a letter of authorisation showing that the submitting party is authorised on behalf of the sponsor to submit the standard research file for assessment.
The legal representative must be a natural or legal person in the EU who is responsible for ensuring compliance with the obligations of the sponsor (IVDR article 58, paragraph 4).
If it concerns research that takes place exclusively on Dutch territory, whether or not in combination with research in a so-called ‘third country’, then at least one contact person for that clinical research who is established in the Netherlands is sufficient. The sponsor must designate the contact person.
Communications to the legal representative or to the contact person are deemed to be communications to the sponsor.