How To Comply With New Requirements For Companion Diagnostics Under IVDR
Executive Summary
The regulation of 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.
You may also be interested in...
Notified Body Training Session Highlights Need For More Support For SMEs
The EU notified body association, TEAM-NB, is working hard to support industry with its MDR and IVDR compliance efforts. Its first technical documentation training session highlighted where help is likely to be most needed.
25% increase in Demand For Notified Bodies To Assess Annex XVI Non-Medical Products
The EU’s Medical Device Regulation regulates a small group of products with a mainly aesthetic purpose for the first time. How much notified body capacity will these potentially risky products demand?
Turkey Notches Up Two Notified Bodies Under EU’s Medical Device Regulation In Two Weeks
There are now 41 notified bodies in total under the EU’s Medical Device Regulation.