Periodic Safety Update Report (PSUR) Guidance EU MDR
As per Article 86 and Annex III of the (EU) 2017/745 Medical Device Regulation (MDR), Periodic Safety Update Report (PSUR) is part of the technical documentation on post-market surveillance to be drawn up by the manufacturer in accordance with Articles 83 to 86 throughout the lifetime of the device.
This Whitepaper is focused on:
- The volume of sales of the device and an estimate evaluation of the size and other characteristics of the population using the device
- Records referring to non-serious incidents and data on any undesirable side-effects
- Information from trend reporting
- Relevant specialist or technical literature, databases and/or registers
- Information, including feedbacks and complaints, provided by users, distributors and importers
- Publicly available information about similar medical devices
