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)
- Submissions to the review committee can be made to the MREC concerned.
- Submissions to CCMO as review committee can be made through firstname.lastname@example.org.
- Submissions to CCMO as competent authority can be made through email@example.com.
- Submissions through ToetsingOnline continue to proceed in the same manner.