Cost Of Certification Under IVDR Is Going To Be Huge As Manufacturers Battle Hurdles
There has been no recent impact assessment as to how business will be affected by the text of the IVD Regulation that was finally adopted. Consultant Robyn Meurant explains how industry will be paying a high price, and why many IVD companies could go under.
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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.