The guidance document, which provides information about the content, format and frequency of preparation for the PSUR, which must be prepared during and after the transition to MDR, provides a detailed analysis of the medical devices that require or not to be prepared PSUR in the first part. In particular, the distinction between legacy devices, which have not completed the MDR transition under Article 120 but continue to be released after May 26, 2021, and devices not released after May 26, 2021 (old devices), clearly answers the questions in the minds of manufacturers.
For the PSUR requirement covering Class IIa, IIb and III devices within the framework of EU MDR 2017/745 Articel 86, it will be a useful approach for many manufacturers to decide by examining the flow diagram given in the guide document in terms of MDD (Article 120) devices. Likewise, it can be used to prepare an accurate and sufficient PSUR with the data collection periods in the fifth section.
As a basic approach;
- For Class IIa devices, every 2 years,
- For Class IIb and Class III devices, annually.
PSUR shall be prepared. EUDAMED registration is required for Class III and IIb implanted devices.
You can contact our team to get detailed information about other PMS, PMCF requirements of PSUR and MDR.