Commission publishes Monitoring of Notified Bodies: new MDR and IVDR reports

The European Commission has just published the most recent Monitoring of Notified Bodies: new MDR and IVDR reports. These are reports, required by Article 44.12 of the MDR and Article 40.12 of the IVDR, that present the results of monitoring and on-site assessment activities by EU Member States regarding notified bodies. The reports are submitted to the European Commission and to the MDCG at least once a year. The reports themselves are confidential. However, nonconfidential summaries are published in EUDAMED.