The European Commission (EC) has taken new measures to relieve some of the pressure on Notified Bodies and free up capacity to perform medical device and in vitro diagnostic (IVD) conformity assessments. Notified Bodies are assessed and monitored by Competent Authorities and the EC according to Articles 35-50 of the Medical Devices Regulation (MDR), and Articles 31-46 of the In Vitro Diagnostic Medical Devices Regulation (IVDR). Every three years a complete re-assessment of the Notified Body is required, taking a significant amount of time for all parties involved…
