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|
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!!
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