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Explore IQVIA by region
As a global community, IQVIA continuously invests and commits to advancing human health.
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EMEA Thought Leadership
Folleto
IVDR Essentials: How to adapt to the upcoming IVDR
Understand the key changes of the IVDR and build a strategy and plan for IVDs to comply with the new requirements
Oct 11, 2021
- Library
- IVDR Essentials: How to adapt to the upcoming IVDR
The transition to the new In vitro diagnostic regulation (IVDR) will require adopting a life-cycle approach. The purpose of the IVDR is to ensure that all in vitro diagnostic (IVD) medical devices used in the EU are compliant, therefore medical device and diagnostic companies will need to develop a strategy and plan to effectively for obtaining CE mark for IVD devices. This brochure offers guidance on how to build an IVDR strategy and breaks down the key changes from the directive to the regulation, as well as essential information of the IVDR.