General Considerations
The most common reasons for delays in Technical Documentation assessments by notified bodies are:
• Incomplete Submissions – Insufficient or missing information not provided that is required for the conformity assessment activities. This includes an incomplete or inconsistent description of devices covered by the application and the related Technical Documentation (variants, accessories, combined devices covered by the Basic UDI-DI to be assessed).
• Lack of Cohesive Structure of Technical Documentation – The information is presented within the Technical Documentation but is difficult to locate.
To avoid delays and to further improve your submission, please consider the following practical points:
Communication with the notified body before an application is lodged
✓ Manufacturers should contact their notified body to clarify the language requirements for the technical documentation submission of the individual notified body as mentioned in MDR Article 52 (12).
✓ Manufacturers should also contact their notified body to clarify the requirements related to documentation labelling and methods for submission to the notified body.
✓ Additional guidance on topics suitable for discussion with the notified body prior to
submission are provided in MDCG 2019-6 Section: I.6.3. What is considered “structured
dialogue”?…
