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Periodic Safety Update Report

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Periodic Safety Update Report

One of the curiosities of the new European Medical Device Regulation (MDR) EU 2017/745 is the requirement to prepare Medical Device Periodic Safety Update Reports (PSUR-MDR Article 86, IVDR article 81) and Post Market Surveillance Reports (PMSR-MDR article 85, IVDR article 80). While the PSUR is not new to the pharma world, it is a fairly new concept to medical devices. It should be noted that PSUR and PMSR are new requirements under the completely revised post market surveillance activities defined by the MDR.

The objective of the Periodic safety update report is to present a comprehensive and critical analysis of the risk-benefit balance of the product, taking into account new or emerging safety information in the context of cumulative information on risk and benefits

A Periodic Safety Update Report (PSUR) is essentially an extension of Post Market Surveillance Report. The PSUR is intended for moderate and high-risk medical devices (class IIa, IIb, III, implantable). It summarizes the results and conclusions of the PMS data.

Contents of Periodic Safety Update Repot (PSUR)

Does your device require Periodic Safety Update Report (PSUR) or Post Market Surveillance Report (PMSR)?

All the devices require one of these reports. The table below summarizes which report is required and when. The requirements between MDR and IVDR are quite similar.

TYPE MDR OR IVDR CLASSIFICATION PMSR OR PSUR? HOW TO SUBMIT? FREQUENCY
MEDICAL DEVICE CLASS I PMSR Only upon request When Necessary A Notified Body or Competent Authority May Request
CLASS IIa PSUR During Notified Body Conformity Assessment Review At Minimum Every 2 Years
CLASS IIb (Non- Implantable) PSUR During Notified Body Conformity Assessment Review At Minimum Every Year
Class II b (Implantable) PSUR Maybe Via EUDAMED or Notified Body Review At Minimum Every Year
Class III (All) PSUR Maybe Via EUDAMED or Notified Body Review At Minimum Every Year
IVD CLASS A AND B PMSR Only upon request When Necessary A Notified Body or Competent Authority May Request
CLASS C PSUR During Notified Body Conformity Assessment Review At Minimum Every Year
CLASS D PSUR Maybe Via EUDAMED or Notified Body Review At Minimum Every Year

PERIODIC SAFETY UPDATE REPORT (PSUR)- STRUCTURE

PSUR

  • Meta- information
  • Planned Implementation
  • Product data
  • Overview of data
  • Analyses
  • Action
  • Conclusion
  • Analysis

EUDAMED TO SUBMIT PSUR?

The PSUR and PMSR are just two examples of many new demands being placed on manufacturers by the new European Medical Device Regulation. It can be difficult to make sense of it all but there are ways we can help. If you already know about the changes and need help updating procedures, coming up with a PSUR template or conducting a gap analysis, consider letting our team assist you with MDR transition.

We’d be glad to help!!
Kindly Contact:

MAVEN PROFCON SERVICES LLP.
Address:
1121, Sun Avenue One Near Sun Prima,
Ambawadi, Ahmedabad, Gujarat 380006
Ph No.- 074900 17774

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