All terms
Periodic Safety Update Report
Periodic EU MDR/IVDR report summarizing post-market surveillance findings.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
Per EU MDR Article 86, the PSUR summarizes results and conclusions of analyses of post-market surveillance data, including main findings of the PMCF, the rationale and description of preventive and corrective actions, and the volume of sales. What the regulation says
The Periodic Safety Update Report (PSUR) is a key post-market surveillance document required under the EU Medical Device Regulation (EU MDR) in Article 86. It provides a comprehensive summary of post-market surveillance data, including findings from Post-Market Clinical Follow-up (PMCF) and the rationale for preventive and corrective actions. The frequency of PSUR submission is risk-based, with Class IIb implantable and Class III devices typically requiring annual reports that are subject to assessment by a Notified Body.What this means in practice
PSUR frequency depends on device classification. Class IIb implantable and Class III devices require annual PSURs assessed by Notified Bodies.Examples
- A manufacturer of a Class III orthopedic implant submits an annual PSUR detailing field safety corrective actions implemented due to a higher-than-expected revision rate identified through vigilance data.
- A company developing a Class IIb active implantable device includes a section in their PSUR outlining the results of their PMCF study, demonstrating the long-term efficacy of the device in a larger patient population.
- A MedTech firm
Common pitfalls
- •Failing to integrate findings from all post-market surveillance activities, such as PMCF, into the PSUR is a common mistake.
- •Submitting a PSUR that lacks clear justification for chosen preventive and corrective actions can lead to regulatory non-compliance.
- •Incorrectly determining the submission frequency of the PSUR based on device classification or regulatory updates is a frequent error.
- •Omitting quantitative data, such as sales volumes, or qualitative insights that support the conclusions in the PSUR will lead to an incomplete report.
- •Not adequately linking the PSUR content to an updated risk-benefit assessment of the device can be a significant oversight.
Frequently asked questions
The primary purpose is to systematically report on the safety and performance of a MedTech device post-market, drawing conclusions from gathered surveillance data to ensure ongoing compliance and patient safety.
Cross-references
Related terms
Shared paths + categoryPost-Market
Post-Market Surveillance(PMS)
Activities to monitor device safety and performance after market release.
Post-Market Mastery · adjacent
Regulatory
EU Medical Device Regulation(MDR)
Regulation (EU) 2017/745 governing medical devices in the European Union.
EU MDR Essentials
Post-Market
Medical Device Vigilance
Reporting and management of serious incidents and field safety corrective actions.
EU MDR Essentials · adjacentPost-Market Mastery · adjacent
Post-Market
Field Safety Corrective Action(FSCA)
Action taken to reduce a risk of serious deterioration in health associated with a device.
EU MDR EssentialsPost-Market Mastery
Post-Market
Medical Device Recall
Removal or correction of a marketed device that violates FDA law.
Post-Market Mastery
Post-Market
Medical Device Reporting (FDA)(MDR)
FDA mechanism for receiving reports of device-related deaths, serious injuries, and malfunctions.
Post-Market Mastery
Latest in MedTech
Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
EUR-Lex·1FDA·2
- 1EU MDR Article 86VerifiedEUR-Lexeur-lex.europa.eu
- 2FDA MAUDE DatabaseVerifiedFDAaccessdata.fda.gov
- 3FDA Recalls - Medical DevicesVerifiedFDAfda.gov
Inline markers like [1] jump to the matching reference above.