EU MDR Notified Body Designations Could Soar By A Third By End Of 2021

09 Mar 2021

There could be 28 notified body designations in total under the Medical Device Regulation by the end of 2021. But there is cause for concern over designations under the IVD Regulation, which are lagging far behind.

muratart/Shutterstock.com — Number of MDR notified bodies set to take off?

There could be another nine notified bodies designated against the EU’s Medical Device Regulation within the next nine months. That would bring the total to 28 under the new regulation, which applies on 26 May.

But it looks as if only one of them will be designated imminently and another one within the next couple...