Italy: The MDCG's explanatory note on codes concerning in vitro diagnostic medical devices

In brief

In July 2021, the Medical Device Coordination Group (MDCG) published an explanatory note on the use of codes for certain types of in vitro diagnostic medical devices, the purpose of which is to specify the scope of designation of notified bodies responsible for their assessment. In particular, this note clarifies how manufacturers should assign codes when submitting an application for conformity assessment to a notified body.


Contents


In depth

Said note also specifies that notified bodies, after having verified the correctness of the codes assigned by manufacturers, shall use these codes to identify within their organization the personnel authorized and qualified to conduct the conformity assessment in accordance with the specific applicable procedures.

Lastly, the note provides an illustrative table of the different types of codes and the medical devices corresponding to them together with a summary of the main characteristics of each in order to simplify the assignment of the codes themselves and the consequent assignment of the competent resources for conformity assessment.

Contact Information
Roberto Cursano
Partner at BakerMcKenzie
Rome
roberto.cursano@bakermckenzie.com
Riccardo Ovidi
Associate at BakerMcKenzie
Rome
riccardo.ovidi@bakermckenzie.com

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