Support in Clinical Investigation Documentation

Annex XV of the MDR outlines the requirements for the documentation regarding the application for Clinical investigations to be conducted within the European Union. These requirements include the submission of necessary documentation to ethics committees and competent authorities. LAS team is capable of supporting the preparation of the mandatory documents to achieve compliance with these requirements. Through an integrated approach, assistance is provided in:

• Structuring Clinical Investigation Plans (CIPs): Clear and detailed guidance is offered for creating CIPs that meet the requirements of Annex XV of MDR, ensuring all essential elements.

• Preparing Investigator’s Brochure and Informed Consent Documents: Support is provided in developing Investigator’s Brochures and informed consent forms, ensuring the protection of the rights, safety, and well-being of study participants while meeting MDR requirements.

• Developing Clinical Investigation Reports (CIRs) and Supporting Documentation: The team ensures that final CIRs and supplementary materials are meticulously prepared, accurately reflecting study results and aligning with regulatory expectations.

• Assistance with completing specific forms for local ethics committees and Competent Authorities in different countries is also provided.

By offering expertise and practical support in these areas, this unit facilitates the preparation and submission of essential documentation to ethics committees and competent authorities, ensuring that clinical investigations meet the rigorous standards set forth by the MDR framework.