MedTech industry is desperately waiting for more Notified Bodies to be designated under the MDR and IVDR. Two more organizations have now been appointed.
You may already have heard the rumors before – but with the name being published on the NANDO database, TÜV Rheinland LGA Products GmbH has officially been designated under Regulation (EU) 2017/745 on medical devices (MDR).
Manufacturers may now choose between five Notified Bodies that are authorized to issue CE certificates under the MDR. Although slowly increasing, the number falls short of the organizations that are currently designated under the Medical Devices Directive 93/42/EEC (MDD) and Active Implantable Medical Devices Directive 90/385/EEC (AIMDD).
In addition, the first Notified Body, DEKRA Certification GmbH from Germany, has been appointed under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). It goes without saying that further assignments are desperately needed for the IVDR as well.