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