Module 15 Presentations

4/15/2024

Annex II

Technical Documentation

1. Device Description 2. Labels and IFU 3. Design and manufacturing 4. GSPRs

5. Risk management 6. Verification and Validation

• Preclinical data • Clinical data • Additional information for Specific cases

Annex III

1. PMS Plan 2. PSUR/PMS report

27

© NAMSA 2021

27

The PMS Process

PMS

Key MDR requirements:

P ost M arket S urveillance

 Requirement for all devices

 Active, systematic continuous process

 Proportionate and appropriate for the device and risk class

 Feedback into multiple processes

28

© NAMSA 2021

28