New study
METC Stichting BEBO only reviews IVDR- and MDR studies that are linked to a CTR study or an other WMO-reserch-study.
The submission of the IVDR- or MDR study, respectively, should be approximately contemporaneous with the submission of the CTR study so that the IVDR- and MDR study can be discussed at the same meeting as the CTR study or the other WMO-research study .
More information on the submission of the combination of IVDR- respectively MDR-studies with CTR-studies and the timelines of these studies, can be found on the CCMO website: Combined studies (CTR/IVDR/MDR) | Investigators | The Central Committee on Research Involving Human Subjects
This is important to be able to discuss both studies in the same meeting.
For the submission of the combination of IVDR or MDR study with an other WMO-research study, we recommend submitting the IVDR or MDR study two weeks earlier via the research portal, than the other WMO study. In that case, both studies can be discussed in the same meeting.
IVDR Research
It is important that the cover letter also contains the title and CT number of the associated CTR study.
MDR Research
It is important that the cover letter also contains the title and CT number of the associated CTR study.
Assessment
After the meeting, you will be notified of the METC’s requirements within approximately 5 business days. We look forward to receiving the revisions with a resubmission.
Completion
In case of a positive decision, you will be notified and we will proceed to prepare a Letter of Approval. Should circumstances prevent us from meeting the specified timeline, you will be contacted.
Amendments
Please submit an amendment for an MDR or IVDR study at the same time as the corresponding CTR amendment so that they can also be reviewed at the same time.
Amendments to MDR and IVDR studies should be submitted through the research portal.
Safety update
The submission of annual safety reports and line listings is not mandatory according to the IVDR and MDR. But the Committee should be informed about serious adverse events or deficiencies in the device by submitting the MDCG 2020-10/2 safety report via the Research Portal.
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