Medical Device Industry Group Webinar Series: In the Dawn of the EU IVDR New Laws Apply for In-Vitro-Diagnostics and Companion Diagnostics

Medical Device Industry Group Webinar Series: In the Dawn of the EU IVDR New Laws Apply for In-Vitro-Diagnostics and Companion Diagnostics

• Wednesday, May 25, 2022 10:00 AM - 11:00 AM

Please join us for a webinar on the new EU Regulation 2017/746 on in-vitro-diagnostics that starts to apply on 26 May 2022. The IVDR revises the legal framework for IVDs with new and additional requirements to companies and products. To mention a few, new rules apply to the classification and clinical evaluation of IVDs as well as for clinical studies, labelling, post-market surveillance and liability aspects. The webinar will also discuss the new rules for companion diagnostics (CDx), including the specific laws for performance studies with CDx. These are not only relevant for diagnostic companies but also for pharma companies that use CDx.

The new laws will apply from 26 May 2022 but transition periods apply to the distribution of certain IVDs which we will explain during the webinar. The implementation of the IVDR presents many practical and legal challenges.

We look forward to discussing the IVDR and its practical implications with you. We also invite attendees to submit their questions to our speakers ahead of the webinar.

Speakers:

Dr. Dr. Adem Koyuncu, Partner
akoyuncu@cov.com 

Click here to Register.

Wednesday, May 25, 2022
4 - 5 p.m. CEST
10 - 11 a.m. EDT
9 - 10 a.m. CDT

Log-in details will be provided upon registration.

CLE credit will be offered.

Event Closed to the Press.