Best Practice Guidance for the Submission of EU Technical File and Documentation of Medical Devices
Updated: Jun 15
This best practice guidance document has been developed by members of Team NB who have reviewed the best practice guidance documents submitted by individual Team NB notified body members, with the purpose to develop a unified approach on the expectations of technical documentation submissions from manufacturers.
This technical file and documentation submission guidance is aligned to the requirements of Medical Devices Regulation [MDR] (EU) 2017/745, described in detail in Annexes II and III of Regulation (EU) 2017/745.
The most common reasons for delays in Technical Documentation reviews 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.
EU Technical documentation submission steps:
Where appropriate the most recently updated comprehensive reports and data should be included. Abbreviated or partial test reports are not considered acceptable.
Verification reports provided should be complete, i.e. not a report with subsequent amendments or revisions as the device was changed.
The technical documentation should document how the manufacturer ensures compliance to every applicable MDR Annex I GSPR. Note that, per section, a simple collection of test/verification reports does not fulfil this requirement.
There are many areas of the technical documentation that will require the duplication of information for multiple documents such as device description. Please ensure that the information is correct throughout all areas where this information is duplicated and consider the risk of potential errors/inconsistencies when updating (e.g. Basic UDI-DI, UDI-DI, intended use, indications for use, contraindications, warnings, etc.).
Ensure the data in the technical documentation is consistent with the data provided in the respective application forms.
Valid justifications should always be provided or accompanied where there are deficiencies in the requested data.