WEBINAR RECORDING | Regulatory tips for Medical Device and IVD developers

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.

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.
March 9, 2023

Watch Asphalion expert Vanesa Palau on her overview about PSURs for Medical Devices and the requests by the Notified Bodies.

We would like to thank everyone for the interest shown in our webinars and we look forward to sharing much more knowledge and experience with our audience.

Check out our website and our posts! New webinars coming soon!

You can now watch the Vigilance MD: PSURs for Medical Device – What is expected by the Notified Bodies? Webinar here:

For further information, please feel free to contact us at: info@asphalion.com

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