EU IVDR PSUR under Article 81: Annual Safety Reporting for Class C and D Devices

1. Key takeaways

Manufacturers of Class C and Class D devices must prepare a Periodic Safety Update Report (PSUR) for each device and, where appropriate, for each category or group of devices. The PSUR summarises the results and conclusions of the analyses of the data gathered under the Article 79 post-market surveillance plan, together with a justification and description of preventive and corrective actions taken, and it must be updated at least annually (Article 81(1)). For Class D devices, the PSUR must be submitted to the notified body involved in the conformity assessment through the electronic system referred to in Article 87, which reviews the report and enters its assessment into that system (Article 81(2)). For Class C devices, the PSUR is made available to the notified body and, upon request, to competent authorities (Article 81(3)). The PSUR cycle therefore rewards manufacturers who treat periodic reporting as a standing process with fixed owners and calendars, rather than as an annual document scramble.

2. Legal basis

3. Expert insights

Insight 1: Of the three mandatory contents of the PSUR, the third is the one most often diluted.

Article 81(1) requires the PSUR to set out, throughout the lifetime of the device: (a) the benefit-risk determination; (b) the main findings of post-market performance follow-up (PMPF); and (c) the sales volume of the device and an estimate of the size and other characteristics of the population using the device, and, where practicable, the usage frequency of the device. Element (c) is decisive because the sales and population data form the denominator of the benefit-risk determination. Without a defensible denominator, the conclusions in (a) cannot be substantiated: a stable complaint count against a growing or shrinking installed base tells a very different story. Yet this is the section most frequently filled with placeholder text. A credible practice is to reconcile sales figures with distribution records at each cycle and to state the estimation method used for the user population, so that the denominator evolves with the market rather than being copied forward.

Insight 2: Class C and Class D face different submission intensity.

Article 81(2) establishes for Class D devices a closed loop of submission, notified body review, and entry of the assessment into the electronic system, with the PSUR and the notified body’s assessment made available to competent authorities through that system. Article 81(3), by contrast, requires only that the manufacturer makes the PSUR available to the notified body and provides it to competent authorities upon request. Class D manufacturers therefore carry an additional review cycle and the potential for resulting corrective obligations, which must be planned into the annual reporting calendar rather than discovered after submission. Where the notified body’s assessment identifies deficiencies, the resulting actions should be tracked to closure under the CAPA system, with the resolution reflected in the next PSUR.

Insight 3: The PSUR is technical documentation and must not be merged with the PMS Report.

The second subparagraph of Article 81(1) states expressly that the PSUR forms part of the technical documentation referred to in Annexes II and III. Class A and Class B devices follow the Article 80 PMS Report route instead: that report is updated when necessary and made available upon request. The two documents differ in scope, in content structure and in update rhythm, and there is no legal basis for combining them into a single periodic document. Keeping the templates separate avoids both audit findings and unnecessary restructuring later.

Insight 4: The status of the Article 87 electronic system shapes the Class D submission route.

Article 81(2) depends on the electronic system for vigilance and post-market surveillance referred to in Article 87. Under Article 113(3)(f), obligations connected with EUDAMED are subject to staged application until EUDAMED is fully functional. As of the verification date of this article, the vigilance and post-market surveillance modules have not yet been declared functionally complete (see article No. 40 in this series), so Class D manufacturers should track subsequent Commission notices and confirm the operative submission route with their notified body before each reporting cycle rather than assuming a fixed channel. Building the PSUR data pipeline so that it can feed either channel is a low-cost hedge against the transition.

4. Practical recommendations

1. Establish an annual PSUR calendar with named responsible owners for each Class C or Class D device, category or group, so the at least annual rhythm is never breached.
2. Build data templates around the three content elements of Article 81(1), and secure hard data for the sales volume and user population estimate under element (c).
3. For Class D devices, agree with the notified body on submission format, review feedback timelines and any corrective follow-up deadlines in advance.
4. Cross-reference the PSUR with the Performance Evaluation Report and the risk management file, consistent with Article 56(6), so the documents stay mutually consistent.
5. Track Commission notices on the functional status of the Article 87 electronic system, and confirm whether the Class D submission route has changed before each submission.

5. Verification checklist

• □ A PSUR has been established per device / category / group (Article 81(1))
• □ The PSUR contains all three elements: (a) benefit-risk conclusion, (b) PMPF findings, (c) sales volume and population estimates
• □ An update rhythm of at least annual frequency has been set
• □ The submission–review–entry process for Class D devices has been agreed with the notified body (Article 81(2))
• □ The availability and on-request provision arrangements for Class C devices are documented (Article 81(3))
• □ Functional notices on the Article 87 electronic system are on the tracking list

Legal information verified as of 29 October 2026.

GRZAN supports IVD manufacturers on the EU market with the full PSUR lifecycle: building Article 81 reporting calendars, assembling sales and population denominator data, coordinating Class D submissions and notified body review follow-up, and integrating PSUR content with PMPF, performance evaluation and vigilance records. For support with periodic safety reporting under the IVDR, contact info@grzanglobal.com.