EU IVDR’s First certification for the type of IVD and Notified Bodies Procedures
A short article based on MDCG 2021-22 guidelines on “first certification for the type of devices and the corresponding procedures to be followed by the Notified Bodies, ” established based on Article 106 of Regulation 2017/745 for Class D IVDR devices. Additionally, this guide talks about the conditions to be followed by the Notified bodies, whether to consult the expert panel for the performance evaluation report of the IVDR devices. According to Article 48(6) of IVDR 2017/746, th...
