B1. ABR form
The ABR form is the General Assessment and Registration form. You are required to complete the ABR form (version May 2021) in ToetsingOnline.
Please note! When finalising the ABR form you are required to select either an accredited MREC or CCMO to submit your file to. In the case of clinical investigations that fall under article 62 or 74.2 of the MDR, the study must be submitted to CCMO for validation. After a positive validation decision, CCMO forwards your file to the review committee (accredited MREC or CCMO) which you have indicated as your preference in the cover letter. If you have not indicated a preference, CCMO determines which review committee will assess your clinical investigation. CCMO transfers the ABR form in ToetsingOnline to this review committee. In all other cases you may submit the file directly to the review committee that you have selected in the ABR form.
Please note! In case of a clinical investigation under the MDR you must fill in question C17 regarding the details and classification of the medical device.
Please note! It is not required to modify the blocked questions at C17a for studies with a positive decision before May 26, 2021.
An example of an ABR form is available.