In vitro diagnostic medical devices (IVD) must achieve the performance declared by the manufacturer, in particular, as appropriate, in terms of analytical sensitivity, diagnostic sensitivity, analytical specificity, diagnostic specificity, accuracy, repeatability, reproducibility, including the control of the known relevant interferences with other products, and with regard to the detection limit of the examined parameter.
The manufacturer demonstrates that these requirements are met by a combination of relevant scientific literature and performance studies. Depending on the type of IVD, the validation of this data is certified by a notified body or by self-certification.
New In Vitro Medical Device Regulation (IVDR)
The European Regulation (EU) 2017/746 on In Vitro Medical Devices (IVDR) entered into application on 26 May 2022. 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.
Below you can find the links to several Belgian and European guidelines and documents concerning performance studies under the IVDR. All questions concerning these studies may be sent per mail to ct.rd@fagg.be
Please note that the Belgian guideline and this website will be updated regularly according to the most recent information. Please make sure to always consult the latest version of each document.
European legislation and guidelines
- The MDCG 2025-5 questions & answers regarding performance studies of in vitro diagnostic medical devices under regulation (EU) 2017/746
- European Regulation (EU) 2017/746 on In Vitro Medical Devices (IVDR)
- The MDCG 2022-20 guidance on general principles of clinical evidence for IVDs
- MDCG 2022-10 – Q&A(link is external) on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
Belgian legislation
- Law of 15/06/2022 on in-vitro diagnostic medical devices
- Royal Decree of 25/09/2022 on performance studies of in vitro diagnostic medical devices
Belgian guidelines and documents
- Guideline on Submission Processes of Performance Studies according to IVDR in Belgium (version 6.0). This document aims at providing guidance for the different submission processes for clinical investigations under the new regulation from a national point of view.
- Guidance on the Belgian synchronized procedure (version 1.0). This document aims at providing specific guidance for sponsors on the synchronized procedure of combined CTR – MDR/IVDR studies within Belgium.
- Zip-folder structure for initial performance study applications including relevant templates
- Template for the list of submitted documents – initial submission
- Template for the list of submitted documents – substantial modifications
- Application form – initial submission (duplicated section 3 - duplicated section 4 - duplicated section 5)
- Application form – substantial modifications
- Template List of GSPR
Other references :
- MDCG endorsed documents and other guidance
- http://www.imdrf.org/documents/documents.asp
- Harmonised standards for in vitro diagnostic medical devices
COMBINE, Coordinated Assessment CI/PS and the Synchronized Procedure
Several projects are currently ongoing at the EU level to improve a harmonized approach of clinical investigations (CI) and performance studies (PS) between the different Member States in the absence of a fully activated European Database on Medical Devices (Eudamed). These projects are available to sponsors as an optional pathway to facilitate the processing of multinational and/or combined studies. More information and updates on the COMBINE project and the Coordinated assessment CI/PS project are published on the website of the EU Commission.
At the national level, Belgium launched the synchronized procedure as it is expected that the complicated COMBINE project won’t be finalized at the EU level within the near future. More information can be found in our guidance dedicated to the synchronized procedure.
Figure 1. Comparison of the ongoing projects.
Ongoing performance studies approved under the European Directive 98/79/ECC
IVD performance studies notified to the FAMHP before May 26th 2022 still fall under the European Directive 98/79/ECC, there is no need for a resubmission under IVDR.
- European directives
- Directive 98/79/ECC on in vitro diagnostic medical devices
- National legislation
- Royal Decree dated 14/11/2001 (French version)
Notification of termination of the performance study
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