Medical Device PSUR and PMSR Submissions
The Post Market Surveillance Report (PMSR) and Periodic Safety Update Report (PSUR) are required to be submitted at periodic intervals as part of Post Market Surveillance (PMS) of a Medical Device and an In-Vitro Diagnostic Device (IVD).
Manufacturers of class IIa, class IIb and class III devices shall prepare a periodic safety update report (‘PSUR’) for each device and where relevant for each category or group of devices summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article 84 together with a rationale and description of any preventive and corrective actions taken.
Schedule of PSUR and PMSR submission for different classes of medical devices and IVDs.
|
Type |
MDR or IVDR Classification |
PMSR or PSUR |
Action To Complete |
Submission Frequency |
|---|---|---|---|---|
| Medical device | Class I | PMSR | Update when necessary and submit upon request | Upon request |
| Class IIa | PSUR | Submit to Notified Body | Every 2 years | |
| Class IIb (non-implantable) | PSUR | Submit to Notified Body | Every year | |
| Class IIb (implantable) | PSUR | Submit via EUDAMED to Notified Body | Every year | |
| Class III | PSUR | Submit via EUDAMED to Notified Body | Every year | |
| IVD | Class A, B | PMSR | Update when necessary and submit upon request | Upon request |
| Class C | PSUR | Submit to Notified Body | Every year | |
| Class D | PSUR | Submit via EUDAMED to Notified Body | Every year |
How We Can Help
- Author PSURs and PMSRs with accurate and complete safety and performance information of the medical device with reference to the PMS Plan
- Reference other documentation such as detailed vigilance reports, Post Market Clinical Followup (PMCF) Evaluation Reports, etc.
- Submit PSUR to EUDAMED For Class III and Implantable Devices
- Make PSUR Available to Notified Body for Class IIa/IIb Non Implantable devices as part of Surveillance
- Using latest technology for rapid completion of PSURs, PMSRs and all other supporting safety and performance related documentation
- Always meeting timelines and avoiding delays and non-compliance risks for medical device manufacturers
