New study

METC Stichting BEBO only reviews IVDR- and MDR studies that are linked to a CTR 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.

More information on the submission of these studies can be found on the CCMO website: Combined studies (CTR/IVDR/MDR) | Investigators | The Central Committee on Research Involving Human Subjects

IVDR Research

Performance studies using in-vitro diagnostics (IVDR) | Investigators | The Central Committee on Research Involving Human Subjects

It is important that the cover letter also contains the title and CT number of the associated CTR study.

MDR Research

Clinical investigations with medical devices (MDR) | Investigators | The Central Committee on Research Involving Human Subjects

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

Amendments to MDR and IVDR studies should be submitted through the research portal.

Rate

Our Rates | Foundation BEBO