The European Society
of Human Genetics


"IVDR - Beneficial or just an expensive straitjacket?"

General Information

Date: Wednesday, June 22, 2022
Time:10:00 - 16:30 hrs
Format: Online Webinar
Programme Outline:

The new IVD EU regulation (IDVR 2017/746) has major implications on the use, availability and associated costs of in vitro diagnostic tests. But on the other hand, it also builds in many ways new assurance points to improve and monitor the quality of our diagnostic services. The previous directive (IVDD 198/79/EC) exempted laboratory developed tests (LDTs / in-house IVD) from all requirements of an IVD. Under the IVDR, LDTs are subject to additional requirements and may only be used if no alternative CE IVD kit is available on the market. A justification for hospital exemption of the use of an IH-IVD has to be given. A European study shows that genetic diagnostics is largely based on tests developed in-house. All players in the field of medical genetics will have to comply with the new European Regulation on in vitro diagnostic medical devices (IVDR) by May 2022 (and for some parts May 2024 and May 2028).

To help laboratories prepare for the IVDR, including compliance with IVDR requirements for in-house devices, the ESHG is hosting a full-day webinar on IVDR, providing the basics and latest updates on implementation, as well as tips and tricks for working towards compliance.
During these webinar presentations we invite speakers from the EU Commission, Notified Bodies, Compent authorities, national IVDR working groups, lab people working on the implementation of the IVDR will share their knowledge and experience.

Who should attend:Clinical Scientists, Lab Technicians, Lab Managers, Quality Managers, Lab Directors, Bioinformaticians

Programme - Wednesday, June 22

Section 1 - Introduction to IVDR  
10.00-10.15General introduction
Presentation includes some theory and practical examples on:

• History,
• short overview
• IH-IVD’s & CE-IVD - Identify devices within scope & risk classification of IVDR 
Els Dequeker, Leuven, Belgium
10.15-10.35Role of the European Commission & Competent Authority
Olga Tkachenko, Brussels, Belgium
Role of different organizations: 
10.35-10.47Role of Notified Bodies & Role of Reference laboratoriesAnja Wiersma, Valburg The Netherlands
10.48-11.00Role of Stakeholders as observers - Biomed AllianceElizabeth Macintyre, Paris, France
Section 2 - IVDR – Impact on a diagnostic laboratory  
13.00-13.30In-house test and hospital exemption – What does this mean?
-   Explanation of article 5.5 (a-i)
-   What about ISO 15189?
-   Key requirements concerning conformity assessment
    •   Technical documentation
    •   General Safety and performance Requirement
    •   How to combine with existing QMS documents and validation data
Els Dequeker, Leuven, Belgium
13.30-14.00MDCG documents for IVDR – some insights:
- How are the guidelines established?
- Snapshot of guidelines for IVDR
Jeroen Poels, Brussels, Belgium
Section 3 - IVDR - Obtain regulatory compliance for IH-IVD’s
National initiatives:  
15.00-15.15 The Netherlands – TF IVDR Clinical Chemistry - Department of Pathology, Princess Máxima Center for Pediatric Oncology, Utrecht, The NetherlandsClaudia Ruivenkamp, Utrecht, The Netherlands
Practical examples - Open questions: 
15.15-15.35 Implementing the IVDR in a diagnostic laboratory - a practical approachIsabel Dombrink, Kiel, Germany
15.35-15.55 Software as an IVD medical device - how to comply to IVDROliver Eidel, Berlin, Germany
15.55-16.30Panel discussion - Questions and answers  

Watch the webinar's recording

Section 1 - Introduction to IVDR

Section 2 - IVDR – Impact on a diagnostic laboratory

Section 3 - IVDR - Obtain regulatory compliance for IH-IVD’s

How to participate?

Participation is free of charge, however registration is mandatory.
The webinar will be held on a Zoom platform.


Mr. Jerome del Picchia
ESHG Society Office
c/o WMA GmbH, Alser Strasse 4, 1090 Vienna, Austria

[e]: courses(at)