Investigator Agreement For Device Studies Template for Germany

The Investigator Agreement For Device Studies is a crucial document required when conducting clinical investigations of medical devices in Germany. It serves as the primary contract between the sponsor/manufacturer and the investigator who will conduct the clinical investigation, ensuring compliance with the EU Medical Device Regulation (MDR), German Medical Device Implementation Act (MPDG), and other applicable regulations. This agreement is necessary whenever a medical device manufacturer wants to conduct clinical investigations in German healthcare institutions, typically during device development, validation, or post-market studies. The document comprehensively covers investigator responsibilities, safety reporting requirements, data protection measures, financial arrangements, and compliance obligations. It must align with German contract law while meeting the specific requirements of medical device regulations and clinical research standards.

1. Parties: Identification of the contracting parties: the sponsor/manufacturer and the investigator, including their full legal names and addresses

2. Background: Context of the clinical investigation, device description, and purpose of the agreement

3. Definitions: Definitions of key terms used throughout the agreement, including technical and regulatory terminology

4. Scope of Investigation: Detailed description of the clinical investigation, including objectives, duration, and number of subjects

5. Investigator Obligations: Core responsibilities of the investigator, including protocol compliance, subject recruitment, and data collection

6. Sponsor Obligations: Responsibilities of the sponsor, including provision of the device, training, and support

7. Compliance with Laws and Regulations: Obligations to comply with MDR, MPDG, and other applicable regulations

8. Safety Reporting: Requirements for adverse event reporting and safety monitoring procedures

9. Documentation and Record Keeping: Requirements for maintaining study records, source documents, and essential documentation

10. Data Protection and Privacy: GDPR compliance and data protection measures

11. Confidentiality: Provisions for protecting confidential information of all parties

12. Intellectual Property: Rights and obligations regarding study-related IP and innovations

13. Publication Rights: Terms for publishing study results and scientific papers

14. Financial Arrangements: Payment terms, schedule, and conditions

15. Term and Termination: Duration of agreement and termination provisions

16. Insurance and Liability: Insurance requirements and allocation of liabilities

17. General Provisions: Standard legal provisions including governing law, dispute resolution, and notices