New MDCG Guidance on Conformity Assessment and Notified Bodies

August 12, 2022

The Medical Device Coordination Group (MDCG) has released a new guidance pertaining to conformity assessment and notified bodies. In part 1 of the guidance, the MDCG seeks to support the process of designating notified bodies in NANDO. In the second part, the guidance goes over the notification process in NANDO and the objection period.

According to Nick Paul Taylor, “MDCG also describes the reassessment process. MDR and IVDR require notified bodies to be reassessed three years after the original notification and every fourth year thereafter. The procedure for onsite assessment of new notified bodies applies “in principle” to organizations undergoing reassessment. The reassessment will look at relevant changes to the notified body’s quality management system since the prior designation. Once the process is complete, the designating authority will update the notification in NANDO.”

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(Source: Regulatory Focus, August 11th, 2022)

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