During and after the clinical investigation
During and after completion of the investigation, you are required to submit information to the review committee, and in some instances to the competent authority medical devices.
The information you need to supply depends on the following points:
- the type of investigation
- whether approval took place before the introduction of the EU regulation medical devices (MDR)
- whether approval took place after the introduction of the EU medical devices regulation (MDR)
All submissions to the review committee (MREC or CCMO) can be made through the Research Portal.