How To Comply With New Requirements For Companion Diagnostics Under IVDR
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...
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.
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?
There are now 41 notified bodies in total under the EU’s Medical Device Regulation.