An Overview of Medical Device Periodic Safety Update Reports (PSUR) and Post Market Surveillance Reports (PMSR) Under the EU MDR
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) and Post Market Surveillance Reports (PMSR). 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.
In this article we will address these common questions:
- What is a PSUR and a PMSR?
- What’s the difference between a PSUR and a PMSR?
- Which one is required for our devices?
- How are they submitted and to whom?
- How often do they need to be updated?
What’s the difference between a PSUR and a PMSR?
The requirement to generate a Post Market Surveillance Report (PMSR) is outlined in Chapter VII, Article 85 of the EU Medical Device Regulation (MDR). The PMSR is intended for low risk Class I devices. It needs to summarize the results and conclusions of your Post Market Surveillance (PMS) data along with a rationale and description of any corrective actions taken for products on the market. This report becomes part of your Technical Documentation (the new moniker for the Medical Devices Directive Technical File) and is updated when necessary and made available to EU Competent Authorities upon request.
The Periodic Safety Update Report (PSUR) is essentially an extension of a Post Market Surveillance Report (PMSR) containing information for higher risk devices. The PSUR is intended for moderate and high-risk devices (Class IIa, IIb, III, implantables). It summarizes the results and conclusions from your PMS data. Additional information provides a summary of post market information, vigilance reporting, and current status of these devices on the market in the EU. Like the PMSR, the PSUR requires you to include a rationale and description of any corrective actions taken for product on the market. The contents of this report are outlined in Article 86 of the MDR. The PSUR should include:
- Conclusions of risk-benefit determination
- Main findings of your Post Market Clinical Follow Up (PMCF)
- Sales volume of the device
- Estimates of size of other characteristics of audience using the device (plus usage frequency if known)
Does our device require a Medical Device Periodic Safety Update Report (PSUR) or a Post Market Surveillance Report (PMSR)?
Yes. All 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.
EUDAMED to submit PSUR?
One thing you may find interesting is that PSURs for high risk devices need to be submitted via an “electronic system.” Articles 86 and 92 do not mention EUDAMED by name, so it is unclear if this will be an electronic system managed through Notified Bodies or entered into EUDAMED. However, Article 33, Section 2(f) is perhaps less nebulous and specifies that EUDAMED shall include “the electronic system on vigilance and postmarket surveillance mentioned in Article 92.” Thus it is not clear if PSUR reports are part of post market surveillance and will be submitted via EUDAMED. There is no certain information on how this will be handled at this time.
The prospect of submitting PSURs has given some medical device manufacturers heartburn for a few reasons. First, if EUDAMED is used, this system is not expected to be accessible to medical device manufacturers until May 2022. Second, remember that requirement about including device sales data in Periodic Safety Update Reports? That’s causing heart palpitations among manufacturers who wonder how “visible” that data will be. It may be that PSUR will only be visible to Competent Authorities and Notified Bodies but this has not yet been defined.
Making a smooth transition to the MDR
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 two ways we can help. If you simply need to get a grip on all of the changes that the MDR will be throwing your way, consider our MDR training class. 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.