Module 16 2024

18/10/2024

PMS outputs and distributing PSURs in the EU

• Purpose of PSURs is for manufacturers to:

o Monitor quality, safety and performance of the device;

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

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

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

Detect and report trends.

o

Manufacturers are making sure that the safety and performance of the device remains “state of the art”.

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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 evaluation report to be uploaded for EUDAMED

• 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

• Not all modules of EUDAMED are fully functional

• Vigilance and Post-market surveillance module is expected from Q4 2024

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