Is Your Organization Ready To Comply With The New EU IVDR Requirements?

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At a Glance

The IVD sector faces significant efforts to plan for and complete before May 2022 to comply with new In Vitro Diagnostic Regulation. The transition from complying with the current IVD Directive to meeting the new IVDR requirements involves significant preparation and data generation to be ready for additional notified body review and scrutiny.


This publication discusses key elements of the In Vitro Diagnostic Regulation (IVDR) and the challenges it presents to manufacturers. The author covers device classification changes, oversight, clinical evidence and performance evaluation, and post-market vigilance. The impact of notified body reductions are discussed as well as some significant changes that could impede market launch for some products.

Publication and Reports you Will Receive

RF Special Report - EU IVDR 

Key areas covered

Device classification changes, oversight, clinical evidence and performance evaluation, and post-market vigilance

Effects of notified body reductions and the consequences

Significant changes may impede market launch for some products.

The scope of the IVDR has not expanded significantly. The breadth of products to be legislated under the IVDR remains the same; however, the depth the expectations for the documentation and review have significantly increased. There are minor tweaks to the wording of the IVD definition, but these are really clarifications that ensure new advances in diagnostics are clearly included within the scope of the IVDR.

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The scope of the IVDR has not expanded significantly. The breadth of products to be legislated under the IVDR remains the same; however, the depth the expectations for the documentation and review have significantly increased. There are minor tweaks to the wording of the IVD definition, but these are really clarifications that ensure new advances in diagnostics are clearly included within the scope of the IVDR. 

Is Your Organization Ready To Comply With The New EU IVDR Requirements?

Download The 
RF Special Report - EU IVDR

Copyright © 2020 Regulatory Affairs Professionals Society. All rights reserved.

Copyright © 2020 Regulatory Affairs Professionals Society. All rights reserved.