Overview on in vitro diagnostic (IVD) products

In Vitro Diagnostic (IVDR) EU 2017/746 Overview Webinar

View On-Demand Webinar

View On-Demand Webinar

Upcoming IVDR Changes

By May 26, 2022, the In Vitro Diagnostic Regulation will be applied to all devices sold in the European Union.

Although the regulation finds its inspiration in the current directive and international standards, it does introduce more stringent requirements to all stakeholders from manufacturers to Notified Bodies and other economic operators.

Through a series of webinars, we will review major impacts introduced by the regulation EU 2017/746.

The first installment will cover the overview of the regulation, we will point the major changes that will impact manufacturers and elements that will be required in order to enter the European Market (i.e. quality management system impact, product review, etc.).

This episode is the first part of a series of webinars. Watch all the episodes here:

IVDR Performance Evaluation and Post Market - Part 2
IVDR Economic Operator - Part 3
IVDR Classification Rules - Part 4

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