Legal Representative for the Sponsor of Clinical Investigations
According to Article 62.2 of the Regulation (EU) 2017/745, when the Sponsor of a clinical investigation (or clinical study) is based outside the EU, a Legal Representative for the Sponsor within the EU must be appointed. The Legal Representative is responsible for handling all communication and ensuring adherence to the Sponsor obligations outlined in the Regulation.
Appoint MDSS as your Sponsor’s Legal Representative in the EU to ensure seamless compliance with the EU regulations for clinical investigations.
Article 62
General requirements regarding clinical investigations conducted to demonstrate conformity of devices
2. Where the sponsor of a clinical investigation is not established in the Union, that sponsor shall ensure that a natural or legal person is established in the Union as its legal representative. Such legal representative shall be responsible for ensuring compliance with the sponsor’s obligations pursuant to this Regulation, and shall be the addressee for all communications with the sponsor provided for in this Regulation. Any communication with that legal representative shall be deemed to be a communication with the sponsor.
Member States may choose not to apply the first subparagraph to clinical investigations to be conducted solely on their territory, or on their territory and the territory of a third country, provided that they ensure that the sponsor establishes at least a contact person on their territory in respect of that clinical investigation who shall be the addressee for all communications with the sponsor provided for in this Regulation.
Let us be your solution!
At MDSS, we ensure your business’s compliance with the Clinical Investigation Sponsor through our comprehensive services:
- Legal Representation: we will allow the Sponsor to disclose MDSS’ name and address as the Legal Representative in the clinical investigation documentation.
- Record of processing activities: we will verify and maintain the application dossier to be submitted to the Competent Authority and ethics committee.
- Cooperation and point of contact with the competent authorities: we will serve as the primary contact point for all communications with the Competent Authority and ethics committee on behalf of the Sponsor.