"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. |
| Who should attend: | Clinical Scientists, Lab Technicians, Lab Managers, Quality Managers, Lab Directors, Bioinformaticians |
Programme - Wednesday, June 22
Section 1 - Introduction to IVDR | ||
| 10.00-10.15 | General 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 |
| 10.15-10.35 | Role of the European Commission & Competent Authority | Olga Tkachenko, Brussels, Belgium |
| Role of different organizations: | ||
| 10.35-10.47 | Role of Notified Bodies & Role of Reference laboratories | Anja Wiersma, Valburg The Netherlands |
| 10.48-11.00 | Role of Stakeholders as observers - Biomed Alliance | Elizabeth Macintyre, Paris, France |
| 11.00-11.20 | Questions | |
| 11.20-13.00 | Break | |
Section 2 - IVDR – Impact on a diagnostic laboratory | ||
| 13.00-13.30 | In-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 |
| 13.30-14.00 | MDCG documents for IVDR – some insights: - How are the guidelines established? - Snapshot of guidelines for IVDR | Jeroen Poels, Brussels, Belgium |
| 14.00-14.20 | Questions | |
| 14.20-15.00 | Break | |
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 Netherlands | Claudia Ruivenkamp, Utrecht, The Netherlands |
| Practical examples - Open questions: | ||
| 15.15-15.35 | Implementing the IVDR in a diagnostic laboratory - a practical approach | Isabel Dombrink, Kiel, Germany |
| 15.35-15.55 | Software as an IVD medical device - how to comply to IVDR | Oliver Eidel, Berlin, Germany |
| 15.55-16.30 | Panel 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.
Contact
Mr. Jerome del Picchia
ESHG Society Office
c/o WMA GmbH, Alser Strasse 4, 1090 Vienna, Austria
[e]: courses(at)eshg.org