Originally published January 2024. Updated November 2026. Since this first ran, the Medical Device Coordination Group (MDCG) issued new post-market surveillance guidance, the first modules of the European Database on Medical Devices (EUDAMED) became mandatory, and a pending European Commission proposal would change how often periodic safety update reports (PSURs) are due.
The European Union Medical Device Regulation (EU MDR), Regulation (EU) 2017/745, became applicable in May 2021, and it hit the medical device industry like an earthquake. It shook the foundations of how companies establish product safety and compliance, and forced them to rebuild the way they evaluate medical devices to meet stricter requirements.
A key component of the EU MDR is the Periodic Safety Update Report (PSUR), required by Article 86. Manufacturers prepare a PSUR for each device or device group at intervals set by classification. A PSUR is mandatory for Class III, IIb and IIa devices. Class I devices do not need a PSUR; they need a post-market surveillance report (PMSR) under Article 85 instead. For Class III and IIb devices the PSUR must be updated at least annually. For Class IIa devices it must be updated when necessary and at least every two years.
Where the PSUR goes also depends on class. For Class III and implantable devices, the manufacturer submits the PSUR to its notified body, which reviews it and adds its own evaluation. For other classes, the PSUR is kept available to the notified body and, on request, to competent authorities.
PSUR documents must include:
- Summary of the device with post-market data: the quantity of devices sold, the countries where it is marketed, and the population using it.
- Analysis of post-market data: the results and conclusions of the post-market surveillance data collected on the device's safety and performance, such as complaints, serious incidents, field safety corrective actions and trends.
- Preventive and corrective actions: the rationale for, and a description of, any preventive and corrective actions taken.
- Volume of sales and estimated usage: an estimate of the size and characteristics of the population using the device, along with sales volume and, where practicable, how often the device is used.
- Benefit-risk determination: the conclusions of the benefit-risk determination, based on the available safety and performance data.
- Main findings from post-market clinical follow-up (PMCF): where applicable, a summary of the main findings from PMCF activities.
Medical device manufacturers now have to manage another document that needs several departments to collaborate. Manufacturers were already struggling to remediate their quality systems to the EU MDR and its existing documentation, and meeting PSUR deadlines became one more obstacle.
Best practices that make PSURs easier to manage include:
- Engage cross-functional teams, and define each team's role and the content it owns, so there is no conflict or confusion when the PSUR is put together.
- Streamline the process with a consistent template that needs minimal changes beyond device-specific data. Build it on the structure in MDCG 2022-21, the Medical Device Coordination Group (MDCG) guidance on PSURs, so notified body reviewers find what they expect where they expect it.
- Use data management tools that can output the necessary information in the same format for every PSUR.
What has changed since 2024
When this article first ran, the PSUR requirement was new and expectations were still forming. MDCG 2022-21, published in December 2022, remains the current PSUR guidance as of November 2026, and it is the reference notified bodies review against. Three developments since then matter for anyone writing PSURs.
New post-market surveillance guidance. In December 2025 the MDCG published MDCG 2025-10, guidance on the post-market surveillance system and plan (MDR Articles 83 and 84). It does not replace MDCG 2022-21. It covers the system that produces the data a PSUR analyzes, which makes it worth reading alongside your PSUR procedure.
EUDAMED is partly live. The European Database on Medical Devices (EUDAMED) is where PSURs for Class III and implantable devices will be submitted. Commission Decision (EU) 2025/2371, published in November 2025, declared the first four modules functional (actor registration, unique device identifier (UDI) and device registration, notified bodies and certificates, and market surveillance), and their use became mandatory on 28 May 2026. The vigilance and post-market surveillance module, which handles PSURs, is not yet one of them.
The original version of this article expected PSURs to become public through EUDAMED. The MDR does not say that directly. Article 92(4) commits the Commission to give healthcare professionals and the public “appropriate levels of access” to the vigilance and post-market surveillance system, without spelling out what that means for individual PSURs. The document written for public reading is the Summary of Safety and Clinical Performance (SSCP) under Article 32, which applies to implantable and Class III devices.
PSUR frequency may change. On 16 December 2025 the European Commission proposed a targeted revision of the MDR and the In Vitro Diagnostic Regulation (IVDR). Among other changes, it would replace the annual PSUR update for Class IIb and III devices with an update in the first year after certification and every two years after that. As of November 2026 the proposal is still with the European Parliament’s public health committee, with a first plenary vote indicated for January 2027. Until it is adopted, the current Article 86 timelines apply.
Why the PSUR matters
The PSUR mandated by the EU MDR takes a risk-based approach to evaluating medical devices, to make sure they remain safe and effective for patients. It provides an evidence-based conclusion that shows the manufacturer is accountable for its device, with patient safety as the primary goal.
Medical device manufacturers must stay proactive and diligent in their compliance and risk management processes to meet EU MDR requirements. If your team needs help building a PSUR process or getting a backlog under control, our regulatory affairs team can help, or get in touch.
Resources: MDCG 2022-21, Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 (December 2022); MDCG 2025-10, Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices (December 2025); Regulation (EU) 2017/745, Articles 83 to 86 and 92.