An Overview of Medical Device Periodic Safety Update Reports (PSUR) and Postmarket Surveillance Reports (PMSR) Under the EU MDR
- usr192162
- 0
- on Feb 13, 2023
One of the curiosities of the European Union Medical Device Regulation (MDR) 2017/745 is the requirement to prepare medical device periodic safety update reports (PSUR) and postmarket 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 postmarket surveillance activities defined by the MDR.
In this article we will address these common questions:
- 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?
- How do they relate to the PMS plan?
What’s the Difference Between a PSUR and a PMSR?
The PMSR is intended for low-risk Class I devices. It needs to summarize the results and conclusions of your postmarket surveillance (PMS) data that you defined in your PMS plan (see MDR Article 84 and Annex III for more details about this document) along with a rationale for and description of any preventive and corrective actions taken for products on the market. This report becomes part of your technical documentation and is updated as needed and made available to EU Competent Authorities upon request.
The PSUR is required for Class IIa, IIb, and III devices. The PSUR is essentially an extension of a PMSR containing additional information for higher-risk devices. Like the PMSR, it summarizes the results and conclusions from your PMS data that you defined in the PMS plan and includes a rationale and description of any corrective actions taken for product on the market. The other specific required contents of this report are outlined in Article 86 of the MDR. The PSUR must also include:
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- Conclusions of benefit-risk determination
- Main findings of your postmarket clinical follow-up (PMCF)
- Volume of devices placed on the market (this can be volume of sales, units shipped, episodes of use for reusable devices, etc.)
- Estimates of size or other characteristics of people using the device (plus usage frequency if known)
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| You’ll find extensive information about the PSUR requirements in MDCG 2022-21, so be sure to download this. |
Does Our Device Require a PSUR or PMSR?
The table below summarizes which report is required and when. The requirement to prepare a PSUR or PMSR applies to legacy device models as well.
| Medical Device Classification | PMSR or PSUR? | Data Collection Begins | How Submitted? | Update Frequency | Conduct Reporting for How Long? | Upload* to EUDAMED? |
| Class I – non-measuring, non-sterile, non-reusable | PMSR – see Article 85 | May 26, 2021 | To Competent Authority upon request | As needed | Not defined but assumed to be lifetime of device as defined in technical documentation | No |
| Class I – reusable* | PMSR – see Article 85 | Legacy MDD certs: May 26, 2021
MDR certs: Date of certification or DOC |
During Notified Body conformity assessment or upon request to Competent Authority | |||
| Class I – measuring, sterile | PMSR – see Article 85 | Legacy MDD certs: May 26, 2021
MDR certs: Date of certification or DOC |
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| Class IIa
Class IIb Class III |
PSUR – see Article 86 | Legacy MDD certs: May 26, 2021
MDR certs: Date of certification |
During Notified Body conformity assessment or upon request to Competent Authority | Class IIa: Every 2 years
Class IIb and III: Every year |
Lifetime of last device placed on EU market – see section 3.2.2 of MDCG 2022-21 | All MDR implantable and Class III devices: Yes*
All other MDD or MDR devices: No*
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*See MDCG 2022-21 section 5.4 and table on page 36 of guidance
Elements of a PSUR Summary
According to section 2.2.2 of MDCG 2022-21, your PSUR must summarize the results and findings after you have analyzed all relevant PMS data. You’ll want to review Annexes I and III of the guidance for details of what is expected. This section also includes a listing of data that should be considered in your PMS data:
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- Information about serious incidents and Field Safety Corrective Actions (FSCA)
- Analysis of nonserious incidents and undesirable side effects
- Trend reporting
- Feedback and complaint data from users, distributors, and importers
- Publicly available data about devices similar to yours
Annex I of MDCG 2022-21 provides a detailed PSUR template you can follow, while Annexes II and III contain advice and templates on how to present data within your PSUR.
What is an “old” medical device versus a “legacy” medical device?An “old” device is defined as a medical device that was placed on the European market before May 26, 2021 – the EU MDR date of application – but is no longer being placed in the European market. PSUR/PMSR requirements do not apply to old medical devices. “Legacy” medical devices hold valid MDD certificates and were placed on the European market after May 26, 2021. PSUR/PMSR requirements do apply to legacy devices under the Article 120 Transitional Provisions. |
Complying With the MDR
The new PSUR requirements are an example of many new demands being placed on manufacturers by the European Union 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 requirements in the MDR, consider our MDR training class. Ready to implement your PMS program? We have a class for that too. 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 compliance.
