The European Commission’s Medical Device Coordination Group (MDCG) has published new guidance covering designation, re-assessment and notification of Notified Bodies (NBs) as well as conformity assessment bodies under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).
Setting expectations for NB designation time frames
The new guidance does not directly address or solve issues related to NB capacity concerns as medical device and IVD manufacturers seek certification or recertification to MDR and IVDR requirements; however, the guidance should help manage expectations related to the time needed for NBs and conformity assessment bodies to obtain MDR and/or IVDR designation…
