IVDR Technical Documentation Submission Checklist

This document serves as a technical report detailing the requirements for submitting technical documentation for in vitro diagnostic medical devices under the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR). It outlines the necessary components of the submission, including the need for an indexed, electronic, text-searchable format, and specifies that documents should be in English and not exceed 100 MB in size. The report includes guidance on the completion of a cover letter, the importance of including a comprehensive table of contents, and the necessity of providing a summary of the submitted documentation. Additionally, it emphasizes the importance of adhering to the Team-NB Best Practice Guidance for submission and outlines specific requirements for different device classes. The checklist aims to assist manufacturers in compiling relevant technical documentation to facilitate an efficient conformity assessment by SGS NB 1639, while also noting that deficiencies in the submission may lead to delays and additional charges.