August 17, 2021

[FEATURED] How To Comply With New Requirements For Companion Diagnostics Under IVDR

The regulation and requirements for companion diagnostics will be far stricter under the IVDR than the current IVD Regulation. EU life sciences regulatory lawyer Elisabethann Wright provides an overview and explains how companies should prepare for compliance.

Do you like it?0
April 27, 2021

[FEATURED] High-Risk Class D IVDs: Some Good News, Some Bad News About IVDR Implementation

The European Commission’s just updated Rolling Implementation Plan for the MDR and IVDR shows delays in key structures for high-risk IVDs. Recent guidance clarifies how and when these products can still proceed to CE marking.

Do you like it?0