Periodic Summary Update Report (PSUR) & Post-Market Surveillance Report (PMSR) for MDR Compliance

Post-market surveillance requirements for medical devices in the EU were significantly enhanced by the requirements of the MDR, of which regular reporting on the use of the device in clinical situations was probably the biggest change for medical device manufacturers. The information documented in the PSUR/PMSR is part of the technical file and, for the PSUR in certain situations, must be directly submitted to the Notified Body for review.

This article is specific to the requirements of medical devices covered under Articles 85 & 86 in the MDR; the separate requirements for IVDs covered under the IVDR are not part of this discussion.

What Is A PSUR For a Medical Device?

A Periodic Summary Update Report (PSUR) for a medical device compiles information on safety and performance gathered through post-market surveillance activities. This includes information from adverse event reporting (e.g., vigilance issues), complaint handling, and other safety information sources, which are defined in the Post-Market Surveillance Plan (PMSP).

Manufacturers need to prepare a PSUR for each device and, where relevant, for each category or group of devices. This should be a standalone document.

If the manufacturer undertakes any Corrective or Preventive actions (CAPAs), the medical device PSUR must include a description and rationale for the actions. The PSUR is also part of a device’s technical documentation and must be updated throughout the lifecycle of the device. The PSUR is initially submitted to a Notified Body during the device’s conformity assessment audit and then at regular intervals thereafter; the frequency of these reviews is dependent on the classification of the device.

What Is The Difference Between PSUR And PMSR?

The PSUR is for higher-classification devices and is more detailed and comprehensive than a Post Market Surveillance Report (PMSR), but both are part of the technical documentation. The PMSR is not reviewed by the Notified Body on a regular basis but must be maintained and made available to Competent Authorities and the manufacturer’s Notified Body on request.

The PMSR and PSUR templates are similar, but the PSUR should provide a comprehensive evaluation of the benefit-risk ratio over a specific period. Therefore, the PSUR template should include sections for summarizing safety data, evaluating risks, and outlining any necessary corrective actions.

MDCG 2022-21: Guidance on Periodic Safety Update Report (PSUR), according to Regulation (EU) 2017/745, gives guidance on the content and format of the PSUR.

While the PMSR template is simpler and summarizes the results of post-market activities, it also focuses on collecting and analyzing post-market data to ensure ongoing compliance and safety.

Table of PSUR vs PMSR

PSUR MDRPMSR MDR
Higher-classification devicesLow-classification devices
Reviewed by the Notified Body on a regular basisNot reviewed by the Notified Body on a regular basis
Should provide a comprehensive evaluation of the benefit-risk ratio over a specific periodSimpler template that summarizes the results of post-market activities
PSUR template should include sections for summarizing safety data, evaluating risks, and outlining any necessary corrective actionsPMSR template focuses on collecting and analysing post-market data to ensure ongoing compliance and safety

How Often Should A PSUR MDR And PMSR MDR Be Updated?

The specific requirements for PSUR MDR and PMSR MDR are determined by the classification of the medical device in compliance with Annex VIII of the MDR. Below is a table defining these requirements:

Table of PSUR MDR and PMSR MDR Frequency Requirements

ClassificationPMSR/PSUR MDRActionFrequency
Class IPMSR MDRUpdate when necessary and upon requestUpon Request or at least every 5 years
Class IIaPSUR MDRSubmit to Notified Body2-years minimum
Class IIb non-implantablePSUR MDRSubmit to Notified Body1-year minimum
Class IIb implantablePSUR MDRSubmit via EUDAMED*1 to Notified Body1-year minimum
Class IIIPSUR MDRSubmit via EUDAMED*1 to Notified Body1-year minimum

How Is The PSUR MDR Submitted To The Notified Body?

Note 1: EUDAMED is not fully operational yet; in this interim period, alternative processes agreed upon with your Notified Body should be used. MDCG 2021-1 Rev 1 provides guidance to manufacturers on the alternative processes that can be used in the interim period before EUDAMED becomes fully operational.

Note 2: A European Competent Authority or your Notified Body can request your PMSR or PSUR at any given time

What Does PSUR Medical Device Contain?

Inputs of medical device PSURs

Table of Inputs medical device PSUR

An analysis and summary of all the information listed above is important because the medical device PSUR is not a box-ticking exercise. The PSUR is an analysis of the actively collected post-market data on the device.

Medical Device PSUR Outputs
  • The risk management file, including the benefit/risk determination, has been updated if required
  • Updates to the design and manufacturing information, IFU, and labelling have been completed if required
  • The clinical evaluation has been updated if required
  • Updates to the Summary of Safety and Clinical Performance (SSCP) have been completed if relevant (*Note: only applicable to Class III and all implantable devices)
  • Preventive and corrective action is complete, including verification of effectiveness checks
  • Reporting of serious incidents and preventive or corrective action to the Competent Authorities and the Notified Body has been completed
  • Confirm that usability, safety, and performance improvements have been made
  • Confirm that opportunities to leverage/use data in the PMS of similar or equivalent devices have been taken
  • Confirm that any detected trends that may impact the safety of patients, users, or other people are reported

How Long Do I Have to Maintain PSURs?

A PSUR medical device is required throughout the device’s lifetime, plus the shelf-life where relevant.

For example, a device could have a lifetime of 3 years and a shelf life of 5 years. After the end of device production (e.g., 2030), the PSUR medical device can be stopped only when the cumulative data of the PSUR issued for this device covers the duration of the shelf life (e.g., 2038 – 3 yrs lifetime + 5 yrs shelf-life = 8 years). Therefore, even though the production of a device may end, the requirements to maintain PSURs can continue for some period after this date.

What Happens If PSUR MDR Requirements Are Not Met?

  1. Regulatory Non-Compliance: Failure to comply with PSUR medical device requirements can lead to non-compliance with MDR, resulting in regulatory actions such as warnings and CE certificate suspension, with the possibility of leading to the withdrawal of the device from the EU market.
  2. Increased Regulatory Scrutiny: Regulatory authorities may increase their scrutiny on the manufacturer, leading to more frequent inspections and audit.
  3. Risk to Patient Safety: Without regular PSUR medical device submissions there is a lack of updated safety information. This can pose risks to patient safety as potential issues may go unaddressed.

 


Kevin Butcher

Kevin Butcher

Kevin Butcher is an experienced Senior Manager with extensive knowledge of medical device regulatory requirements, including Product Technical Files and QMS 3rd Party auditing. Mr. Butcher possesses 18 years of Notified Body experience, latterly as Certification Manager for SGS United Kingdom. Kevin joined the medical device consulting team at NAMSA in January 2021 and currently serves as a Principal Regulatory Consultant.