EU IVDR & MDR Periodic Safety Update Report (PSUR)

EU Periodic Safety Update Report (PSUR) Under MDR & IVDR

If you have a moderate or high-risk device, you already know that your post-market obligations under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) don’t stop once you’ve achieved CE Marking. These regulations require you to proactively collect and evaluate real-world data to confirm that your device continues to perform safely and effectively. Known as the Periodic Safety Update Report (PSUR), this recurring submission is a critical part of your overall Post-Market Surveillance (PMS) activities.

Quick facts about PSUR Requirements: 

• Required in Article 86 of MDR and Article 81 of IVDR
• Essential component of Post-Market Surveillance for moderate- and high-risk devices (Class IIa, IIb, III medical devices and Class C/D IVDs)
• Must be submitted to the Notified Body either annually or biennially, depending on device classification
• Structured according to MDCG 2022-21 guidance
• Supports the ongoing benefit-risk assessment and helps maintain CE certification
• Applies throughout the entire lifecycle of the MD or IVD
• Must be aligned with other technical documentation, including the CER/PER, SSCP (if applicable), and risk management file

How NAMSA Supports Your PSUR Requirements

Preparing a PSUR isn’t just about filling in a template, it’s about demonstrating that your device continues to meet safety and performance expectations in the real world. NAMSA helps manufacturers navigate the complexities of PSUR development with confidence and clarity. Our team understands the regulatory requirements under MDR and IVDR, and we know how to interpret and present your data in a way that satisfies Notified Body expectations. At NAMSA, our regulatory and medical writing teams have supported manufacturers globally in preparing PSURs that are complete, compliant, and ready for review. We will help you develop a PSUR:

• Structuring your PSUR report according to MDCG 2022-21
• Preparing the cover page, executive summary, and device descriptions
• Justifying device groupings and ensuring alignment with technical documentation
• Estimating patient exposure and usage for both single-use and reusable devices
• Compiling and interpreting vigilance data, including serious incidents, trend reporting, field safety corrective actions (FSCAs), and CAPAs, ensuring that each element is clearly documented and traceable
• Integrating general PMCF/PMPF data such as user feedback, complaints, scientific literature, registry data, and public databases, as well as a summary of specific PMCF/PMPF activities including clinical studies and targeted follow-up
• Ensuring consistency across CER/PER, SSCP/SSP, and risk documentation
• Preparing your PSUR for Notified Body review with clarity and traceability

We Know What Your Notified Body Expects to See

After investing significant time and resources into collecting post-market data, the last thing any manufacturer wants is to receive major findings during a Notified Body review. At NAMSA, we understand exactly what reviewers are looking for and how to avoid the common pitfalls that can delay or derail your submission. Our team brings deep experience working with Notified Bodies across Europe, which means we know how to structure your PSUR for clarity, compliance, and successful review.

What sets NAMSA apart is our multidisciplinary approach. Our regulatory, clinical, and biostatistics experts work together to ensure your PSUR is not only technically accurate but also scientifically sound and strategically aligned with your broader documentation. Whether you need support for a single PSUR or ongoing submissions, we offer flexible solutions tailored to your internal resources and timelines.

We also offer a wider range of services than most regulatory consultancies, including clinical trials, preclinical testing, EU market research, and PMCF/PMPF execution. This integrated approach helps us identify and resolve issues early, before they become costly delays.