SYNCNews

In-Vitro Diagnostics Regulations (IVDR) - EU & ISRAEL

September 2020

Topic: In-Vitro Diagnostics Regulations (IVDR) - EU & ISRAEL

Time:September 23, 2020 11:00 AM

Cost: FREE!

Platform: ZOOM (a link will be provided after registration)

Duration: 60-minute presentation plus 30-minute interactive Q&A session.

Discover & learn:

The expected changes by the IVDR will completely change how these devices will be regulated in Europe and in Israel, including NEW classification rules which will require over 80% of IVD devices to be CE Certified by a Notified Body. While IVD manufacturers should invest in planning and advancing execution to meet the new requirements, we will also provide insight on how to register IVDs today, still under the IVDD 98/79/EC Directive, to contribute to the COVID-19 diagnostic challenges.

As such, it is with great pleasure that we invite you to join us for a 90-minute online webinar to learn about the IVDR and its significant changes but also to find out how to launch your IVDs to the European Union in just 6 working days!

Key Topics & Sessions:

Sessions #1 (30 min):

  • Overview of the significant changes for the IVDR.
  • Overview of the EU process to register In-Vitro Diagnostic devices under the IVDD 98/79/EC in 6 working days.

Sessions #2 (30 min):

  • The significance of the new IVDR regulation for IVD manufacturers and importers in Israel.

Sessions #3 (30 min):

  • Interactive Q&A session

(*The number of free participants is limited.
(*)The webinar will be presented in HEBREW with slides in ENGLISH.

Who should participate?

  • Regulatory Affairs & Quality Affairs Professionals
  • Export and Import Managers
  • Senior executives and CEOs of companies engaged in IVD (manufacturers and importers).

Hopping to see you!

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