EU IVDR Annex III: Post-Market Surveillance Technical Documentation, PMS Plan and Reports

1. Key takeaways

Annex III is the post-market surveillance part of the technical documentation, corresponding directly to Articles 78 to 80. Article 10(9) requires the manufacturer to implement and keep updated a post-market surveillance system in accordance with Article 78; Article 79 requires the preparation of a post-market surveillance (PMS) plan; and Article 80 requires manufacturers of Class A and Class B devices to prepare a PMS report, updating it when necessary and making it available to notified bodies and competent authorities upon request.

The practical consequence is that Annex III is not an annex to be filled in after the device has been launched. Its content, the PMS plan in particular, is drafted before placement on the market, reviewed as part of the conformity assessment for higher-risk classes, and then operated continuously for the whole life of the device. A manufacturer that treats the PMS plan as a formality will find that the same weakness surfaces three times: in the notified body assessment, in the periodic updates, and in any authority inspection. The plan must therefore define real data sources, real thresholds and real responsibilities from the outset.

2. Legal basis

3. Expert insights

Insight 1: The PMS plan must first define how an anomaly will be judged, before it discusses data collection.

The second subparagraph of Article 83(1) makes this explicit: the manufacturer must document in the PMS plan how incidents are to be managed, the methods used to establish statistically significant increases in the frequency or severity of incidents, as well as the observed period, including any observed increases in the in-situ performance of devices. In other words, the thresholds and the statistical methods exist as documented content before the data arrive; they are not explanations constructed afterwards. A plan that lists generic data sources without defining what constitutes a statistically significant increase, over which observation period, will not satisfy reviewers, because it cannot demonstrate that the manufacturer would recognise a signal if one appeared.

Insight 2: The PMS report and the PSUR are two distinct documents with different addressees.

Article 80 requires manufacturers of Class A and Class B devices to prepare a PMS report, update it when necessary, and make it available to notified bodies and competent authorities upon request. Article 81 requires manufacturers of Class C and Class D devices to prepare a Periodic Safety Update Report (PSUR), which is updated at least annually; for Class D devices, the PSUR is submitted through the electronic system referred to in Article 87 to the notified body involved in the conformity assessment. Collapsing the two into a single document is a common error: the PMS report is an on-request document summarising the results and conclusions of the PMS system data, while the PSUR is a periodic, actively submitted document with its own summary of the benefit-risk determination. Each class needs its own calendar and its own template.

Insight 3: PMS data must flow back into performance evaluation and risk management.

Article 56(6) requires the performance evaluation and its documentation to be updated with data obtained from the post-market performance follow-up (PMPF) referred to in Annex XIII Part B, and the risk management system under Article 10(2) must likewise remain connected to real-world data. Post-market surveillance is therefore not a self-contained loop. Its outputs, including incident trends, user feedback and PMPF findings, must enter the performance evaluation report, the risk management file and change assessments. Reviewers increasingly test this linkage directly: they pick a PMS finding and ask where it appears in the performance evaluation report or the risk file. If the answer is nowhere, the PMS system is judged ineffective regardless of how well the plan is written.

Insight 4: Legacy devices also require post-market surveillance.

According to MDCG 2022-8, the requirements of Chapter VII of the IVDR concerning post-market surveillance, market surveillance and vigilance apply to legacy devices. Manufacturers must therefore establish a post-market surveillance system based on a PMS plan, under Articles 78 and 79, for devices placed on the market under the transitional arrangements, while parts of the obligations linked to pre-market requirements, such as updating the summary of safety and performance, do not apply. Teams often overlook this scope: a legacy device registered for a limited period still needs a functioning PMS plan, data collection and reporting readiness until its final phase-out, and the applicable scope should be documented explicitly to avoid applying pre-market requirements in reverse.

4. Practical recommendations

1. Draft the PMS plan in accordance with Article 79 and Annex III, defining the data sources, indicators, thresholds, statistical methods, observation period and responsible persons, so that every element required by the second subparagraph of Article 83(1) is addressed explicitly.
2. For Class A and Class B devices, establish the update triggers for the PMS report; for Class C and Class D devices, establish an annual PSUR writing calendar aligned with certificate milestones and data cut-off dates.
3. Establish a one-way data flow from PMS to the performance evaluation report, risk management and change assessment, with record templates that document how each PMS output was assessed and where it landed.
4. Share the data sources between vigilance and trend reporting under Articles 82 and 83 and the PMS system, so that incident counts, severity assessments and thresholds follow a single definition throughout the organisation.
5. Mark the Chapter VII scope explicitly for legacy devices, documenting which post-market obligations apply, so that pre-market requirements are not applied to them in reverse and the phase-out period remains covered by a functioning PMS plan.

5. Verification checklist

• □ The PMS plan has been prepared in accordance with Article 79 and Annex III, including methods and the observation period under Article 83(1)
• □ A PMS report has been prepared for Class A and B devices with defined update triggers under Article 80
• □ An annual PSUR mechanism has been established for Class C and D devices under Article 81
• □ A data flow from PMS to the performance evaluation report, risk management and change assessment has been established
• □ Vigilance and trend reporting share the same data sources and definitions as the PMS system
• □ The Chapter VII scope for legacy devices has been documented in line with MDCG 2022-8

GRZAN supports manufacturers entering or operating in the EU in vitro diagnostic market with complete post-market surveillance documentation under Annex III of the IVDR: PMS plans meeting Articles 79 and 83(1), PMS reports for Class A and B, PSUR calendars and drafting for Class C and D, PMPF integration into the performance evaluation report, and legacy device surveillance scoping in line with MDCG 2022-8. Contact us at info@grzanglobal.com to review your PMS documentation.

Legal information verified as of 29 October 2026.