avril 09, 2024 - avril 09, 2024
/ Europe
Date: 9 April, 2024
Location: Utrecht, The Netherlands
Language: Dutch
Introduction
The subject of this meeting is: 'Ins and Outs of companion diagnostics: the first experiences'.
In recent years, new European regulations have come into effect to improve the safety of medical devices. The requirements for medical devices to qualify for market approval and to remain on the market in the European Union have become stricter, including with regard to clinical evidence. As of May 26, 2021, the European Medical Device Regulation (MDR) came into force. And as of May 26, 2022, the new European regulation for in vitro diagnostics (IVDR) took effect. The new European regulations are directly legally binding in all European member states, including the Netherlands.
The new legislation imposes heightened requirements on manufacturers, resellers, importers, European authorized representatives, and healthcare institutions. Topics that pose significant challenges under the IVDR include companion diagnostics, devices essential for determining the safety and efficacy of a drug, and combined studies.
During the spring meeting, the experiences so far regarding companion diagnostics and combined studies will be discussed, as well as practical challenges encountered. Keep in mind the presentation will be held in the Dutch language.
Several speakers from various perspectives will shed light on the subject:
- Mr. Cécile van der Heijden (AXON Lawyers) will provide an explanation of the legislation.
- Kristiane Schmidt (Qserve; medical device consultancy) will address experiences with combined/performance studies.
- Alex Laan (BSI Group The Netherlands B.V.) will provide the perspective from a Notified Body.
For more information about the event and to register, please visit the event website.
Qserve presenter: