How to Structure Technical Documentation

Send us Fan MailTechnical documentation for the MDR must not only comply with Annexes II and III, but also be easily accessible to the product assessor. A disorganized structure or hard‑to‑find information leads to delays, nonconformities, and wasted time—especially with the upcoming MDD deadlines. The Team NB guideline on the submission of technical documentation provides a valuable reference: the main causes of delays are incomplete files and lack of structural coherence. Avoid non‑searchable PDFs, unusable tables of contents, and duplicated information; instead, ensure data completeness (including raw test data) and consistency of key elements such as the intended use and the Basic UDI‑DI. When documents are updated, changes must be clearly highlighted and described within the quality system. Responses to findings must be complete and self‑contained, and subsequent submissions must include the entire technical file, not just the modified sections. Translations must be accurate and professional. It is also essential to review the specific regulations of the Notified Body, which may include additional mandatory requirements. Finally, it is possible to request a structured dialogue with the Notified Body for procedural clarifications. In short: making the product assessor’s job easier ultimately makes your own work easier.