1. General information
Please be informed that as of 26 May 2022, the European Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR) came into force.
The IVDR introduces a major update of the regulatory framework in the European Union and brings about several changes to the scope of performance studies, clinical studies with in vitro medical devices, that must be submitted for approval/notification, the submission processes for initial application and substantial modifications, submission dossier contents and safety reporting.
1.1. Definition
All definitions provided in this section are compliant with the definitions stated in the IVD Regulation 2017/746.
1.2. In vitro diagnostic medical device
Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software 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 on one or more of the following:
- concerning a physiological or pathological process or state;
- concerning congenital physical or mental impairments;
- concerning the predisposition to a medical condition or a disease;
- to determine the safety and compatibility with potential recipients;
- to predict treatment response or reactions;
- to define or monitoring therapeutic measures.
Specimen receptacles are considered to be in vitro diagnostic medical devices. ‘Specimen receptacle’ means a device, whether of a vacuum-type or not, specifically intended by its manufacturer 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 or research-use only products 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.
1.3. Performance evaluation
A study undertaken to establish or confirm the analytical or clinical performance of a device.
2. A new study
Depending on the type of performance study the submission package and procedure can differ. For more detailed information the ‘Guideline on Submission Processes of Performance studies according to IVDR in Belgium’ document on the website of FAMHP can be consulted. If the study is not covered by the IVDR and does not need to be submitted to the FAHMP, approval of the Medical Ethics Committee (MEC) may still be required following the national law of 7 May 2004. Please follow the procedure and submission package for experiments.
For academic performance studies that fall within the scope of the IVD Regulation for which Ghent University (Hospital) acts as a sponsor: please contact the medical device focus team to arrange a meeting to discuss your performance study before setting-up your submission package.
IVD performance studies notified to the FAMHP before 26 May 2022 still fall under the IVD Directive, there is no need for a resubmission under IVD Regulation.
3. A modification
Depending on the type of performance study the modification submission package and procedure can differ. For more detailed information the ‘Guideline on Submission Processes of Performance studies according to IVDR in Belgium’ document on the website of FAMHP can be consulted. If the study is not covered by the IVDR and does not need to be submitted to the FAHMP, approval of the Medical Ethics Committee (MEC) for the modification may still be required following the national law of 7 May 2004. Please follow the procedure and submission package for experiments (Submission of an amendment).
For modifications to academic performance studies that fall within the scope of the IVD Regulation for which Ghent University (Hospital) acts as a sponsor: please contact the medical device focus team to arrange a meeting to discuss your modification to your performance study before setting-up your modification submission package.
Please note: substantial modifications to IVD performance studies approved under the IVD Directive must follow the IVD Directive procedure, also after 26 May 2022. See website FAMHP. Please follow the procedure and submission package for experiments (Submission of an amendment).