Module 16 2022

9/2/2022

PMS outputs and distributing PSURs in the EU

• PMS for Class IIa and Class IIb will lead to the following output:

• PSUR report • PMS for Class III and Implantable devices have the following outputs: • PSUR report / PSUR report to be uploaded for EUDAMED • In order to meet with the information obligations laid down in article 86 (PSUR), the best approach is to use a format that is in line with EUDAMED requirements • Article 91 MDR (Implementing Acts) calls for adopting detailed arrangements and procedural aspects necessary for the implementation of PSURs and trend reports by manufacturers as referred to in Articles 85, 86, 87, 88 and 89 respectively: not published to date…

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© NAMSA 2021

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PMS outputs and distributing PSURs in the EU

• First and foremost purpose of PSURs is for manufacturers to:

o Monitor quality, safety and performance of the device;

o Identifying needs for preventive, corrective or field safety corrective actions;

o Identifying of options to improve the usability, performance and safety of the device;

o To contribute to the post-market surveillance of other devices, and;

o To detect and report trends.

© NAMSA 2021 • In other words, making sure that the safety and performance of the device remains “state of the art”. 32

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