WEBINAR | Vigilance MD: PSURs for Medical Device – What is expected by the Notified Bodies?

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Article 86 MDR requires manufacturers of Class IIa, Class IIb, and Class III devices to prepare a Periodic Safety Update Report (PSUR) for each device and, when relevant, for each category or group of devices. The MDCG 2022-21 guideline endorsed by the Medical Device Coordination Group (MDCG) provides ideas for manufacturers on how to prepare the PSUR for their Medical Devices.

Asphalion expert Vanesa Palau provides an overview about PSURs for Medical Devices and the requests by the Notified Bodies.

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