The conduct of clinical investigations with a medical device for in vitro diagnostic in the EU is currently governed by the European Directive 98/79/EC on in vitro diagnostic medical devices.

Studies for performance evaluation of an in vitro diagnostic medical device should follow the procedures for experiments.

In addition, the manufacturer of the medical device for in vitro diagnostic is responsible to notify every study intended to test the performance of an in vitro diagnostic medical device (IVD) to the Federal Agency for Medicines and Health Products (FAMHP). More information can be found on the FAMHP website:

Please be informed that the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) will replace the Directive on 26 May 2022. This may have an impact on the submission and approval procedure of your study.

Definition

‘In vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information: 

  • concerning a physiological or pathological state, or 
  • concerning a congenital abnormality, or 
  • to determine the safety and compatibility with potential recipients, or 
  • to monitor therapeutic measures. 

Specimen receptacles are considered to be in vitro diagnostic medical devices. ‘Specimen receptacles’ are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination. 

Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination.

‘Performance  evaluation’  means  an  assessment  and  analysis  of  data  to  establish  or  verify  the  scientific  validity,  the analytical  and,  where  applicable,  the  clinical  performance  of  a  device; 

Submission package

Please refer to the submission package for the Medical Ethics Committee (MEC) approval for experiments.

Submission procedure

  1. Preparation of the submission package
    In case of questions regarding academic studies, please contact the medical device focus team at HIRUZ CTU.
  2. Submission through the Research Portal
    Since February 2022 all studies must be submitted through the Research Portal of Ghent University (Hospital): https://onderzoeksportaal.uzgent.be/
    More information can be found here.

    Studies for performance evaluation of an in vitro diagnostic medical device (IVD) should be submitted as described in the procedures for experiments

    In addition, a notification by the manufacturer to the Federal Agency for Medicines and Health Products (FAMHP) is required. 
  • In case the manufacturer of the IVD is Ghent University (Hospital), the notification to FAMHP will be done by HIRUZ CTU.
  • In case the manufacturer of the IVD is not Ghent University (Hospital), please notify the manufacturer that his IVD is being evaluated in your study and that a notification to FAMHP is required by the manufacturer.
  1. MEC approval
    Information on the legal periods for advice by the MEC can be found here. The study can only start when a favourable opinion from the central MEC has been received and as soon as all agreements are finalized (if applicable). 
  1. Start study – During the study
    Please register the date of start of recruitment and the date of first inclusion in the Research Portal.

    Don’t forget that the sponsor needs to register the study on a publicly accessible website before inclusion of the first participant. For the public database ClinicalTrials.gov, HIRUZ CTU can provide you with the login details if University (Hospital) Ghent is sponsor of the study. For more information, see FAQ

    Please provide an annual progress report to HIRUZ CTU (hiruz.ctu@uzgent.be) (only for academic studies) and the MEC of Ghent University (Hospital) (ethisch.comite@uzgent.be).
    Please note: for the time being, annual progress reports still need to be submitted by email instead of through the Research Portal.
  1. End of study
    Please register the end of the study in the Research Portal and upload the study results within one year after the end of the study (as legally required).

    In addition, a notification of end of trial and submission of a final study report to the FAMHP is required. 
  • In case the manufacturer of the in vitro diagnostic medical device (IVD) is Ghent University (Hospital), the notification of the amendment to FAMHP will be done by HIRUZ CTU.
  • In case the manufacturer of the IVD is not Ghent University (Hospital), please notify the manufacturer that changes have been made to the study in which his IVD is being evaluated and that a notification to FAMHP is required by the manufacturer.

Submission package

Please refer to the submission package for Medical Ethics Committee (MEC) approval for amendment to experiments.

Submission procedure

Please refer to the submission procedure for MEC approval for amendment to experiments.

In addition, a notification of an amendment to the study to the Federal Agency for Medicines and Health Products (FAMHP) is required.

  • In case the manufacturer of the in vitro diagnostic medical device (IVD) is Ghent University (Hospital), the notification of the amendment to FAMHP will be done by HIRUZ CTU.
  • In case the manufacturer of the IVD is not Ghent University (Hospital), please notify the manufacturer that changes have been made to the study in which his IVD is being evaluated and that a notification to FAMHP is required by the manufacturer.