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

February 9, 2023

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.

  • The main objective of this guideline is to assist manufacturers to implement the legal requirements laid down in Article 86 MDR.
  • This guideline is applicable to medical devices which have been certified under MDR and to devices which have been certified under MDD or AIMDD.
  • A PSUR is required throughout the lifetime of the Medical Device.
  • This guideline provides an overview of all post-market surveillance data that should be included in the PSUR, as well as the different sections that the PSUR should contain.

 

Join Asphalion expert Vanesa Palau on this webinar, where she will provide you with an overview about PSURs for Medical Devices and the requests by the Notified Bodies.

Registrations are open. You can register here: PV PSURS FOR MD WEBINAR

For further information, you can contact us at: info@asphalion.com

 

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