Post Market Surveillance Report (PMSR) and Periodic Safety Update Report (PSUR) compose critical documentation of Post Market Surveillance (PMS) of a Medical Device and an In-Vitro Diagnostic Device (IVD). Medical Device and IVD manufacturers with an intent to market the products in the European Union (EU) shall comply with Medical Device Regulation (EU MDR) 2017/745 and In-Vitro Diagnostic Regulation (EU IVDR) 2017/746. Post Market Surveillance, commonly called as PMS, is one such compliance requirement applicable for manufacturers of all device classes and is covered under Articles 83-86 of MDR and Articles 78 – 81 of IVDR. The information, frequency, and submission requirements for PMSR and PSUR vary based on the device class.
The manufacturers of Low-risk Class I Medical Devices and Class A, B In-Vitro Diagnostics (IVDs) should maintain a Post Marketing Surveillance Report (PMSR). The PMSR need not be submitted to any authority for CE Certification of the device. This report should be compiled, updated periodically, and shall be readily available for submission to the competent authority upon request.
The manufacturers of moderate and high-risk Class IIa, IIb, III Medical Devices and Class C, D In-Vitro Diagnostics (IVDs) should submit Periodic Safety Update Report (PSUR). PSUR must be submitted to Competent Authority or Notified Body as a part of technical documentation. The PSUR document is evaluated as part of Conformity Assessment.
The PMSR shall contain summary of results and conclusions derived from analysis of PMS data collected as per the PMS plan. It should also describe the Preventive and Corrective actions taken. The PSUR, on the other hand, shall summarize the results and conclusions derived from the analysis of Vigilance, PMS, and PMCF data collected as per the PMS Plan. It should also describe the Preventive and Corrective actions taken. The PSUR shall include -
- the conclusions of the benefit-risk determination
- the main findings of the Medical Device Post-Market Clinical Follow-up (PMCF) or IVD’s Post-Market Performance Follow-up (PMPF)
- the volume of sales of the device and an estimated evaluation of the size and other characteristics of the population using the device, and, where applicable, the usage frequency of the device
The Reports (PMSR and PSUR) are to be prepared and updated throughout the lifetime of the device. The PMSR shall be updated as and when any new changes are made to the Class I Medical Device or Class A, B IVDs in scope. The PSUR for Class IIa devices shall be updated as and when required and at the least once in every two years. PSUR for Class IIb, III Medical devices and Class C, D IVDs must be updated on annual basis.
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