A2. Authorisation from legal representative EU if sponsor does not hold offices within EU
If the sponsor of the clinical investigation is not established in the EU, you must enclose an authorisation showing who the legal representative is.
The legal representative must be a natural or legal person in the EU who is responsible for ensuring compliance with the sponsor's obligations (MDR Article 62.2).
If it concerns a clinical investigation that takes place solely on Dutch territory, or in combination with an investigation in a so-called 'third country', then one contact person for that clinical investigation who is based in the Netherlands suffices. The sponsor must designate the contact person.
Communications to the legal representative or the contact person will be considered as communications to the sponsor.