EU IVDR Post-Market Surveillance under Articles 78-80: System, Plan and Class A/B Reports

1. Key takeaways

Chapter VII of Regulation (EU) 2017/746 (IVDR) organises post-market surveillance into three coordinated layers. Article 78 obliges manufacturers to establish and continuously update a post-market surveillance (PMS) system; Article 79 requires that system to be backed by a documented PMS plan; and Article 80 requires manufacturers of Class A and Class B devices to prepare a PMS Report, to update it when necessary, and to make it available upon request to notified bodies and competent authorities. Devices of Class C and Class D follow a different reporting vehicle, the Periodic Safety Update Report under Article 81. Importantly, PMS is not a free-standing exercise: it must operate in tandem with the quality management system requirements of Article 10(8)(i) and with the continuous update of performance evaluation under Article 56(6), so that field data actually flows back into design, risk and performance decisions.

2. Legal basis

3. Expert insights

Insight 1: The PMS system is a subsystem of the QMS, not a standalone project. This is the point most often missed by manufacturers transitioning from the IVDD.

Article 10(8)(i) lists the establishment, implementation and maintenance of the PMS system as one of the thirteen mandatory components of the quality management system, and Article 10(9) requires the manufacturer to implement and keep the PMS system up to date in accordance with Article 78. In practice, this means the PMS procedure, its data sources, its responsible functions and its records must be embedded in the same document architecture as design control, supplier management and CAPA. Manufacturers who draft a separate PMS manual that lives outside the QMS routinely fail this test during notified body audits: auditors trace PMS activities through the QMS structure, and any disconnect is scored as an incomplete system rather than as a documentation style choice.

Insight 2: The PMS plan must first define what counts as an anomaly.

The second subparagraph of Article 83(1) requires the PMS plan to describe how the events referred to in the first subparagraph will be managed, the methods used to establish any statistically significant increase in the frequency or severity of such events, as well as any change in device performance, and the applied observation period. The consequence is that thresholds, statistical methods and observation windows must be defined and written down before the data are generated. Choosing a threshold retrospectively, after a rise in complaint rates has already been observed, undermines the credibility of the entire trend assessment and is a frequent audit finding. A workable plan therefore states, for each metric, the baseline population, the calculation formula, the sample size or denominator to be used, and the review interval at which the data will be re-examined.

Insight 3: Class A and B devices report differently from Class C and D.

Article 80 covers only Class A and Class B devices. For them, the manufacturer must prepare a PMS Report that summarises the results and conclusions of the analyses of the data gathered under the Article 79 PMS plan, together with a justification and description of any preventive and corrective actions taken; the report must be updated when necessary and made available to notified bodies and competent authorities upon request. Class C and Class D devices instead use the Periodic Safety Update Report (PSUR) under Article 81, which must be updated at least annually (see the separate article in this series, No. 42). Confusing the two vehicles is a common documentation error, because the audience, content structure and update rhythm differ.

Insight 4: PMS outputs must feed back into performance evaluation and risk management.

Article 56(6) requires the performance evaluation and its documentation to be updated throughout the lifecycle with data from Performance Evaluation Follow-up (PMPF, Annex XIII Part B), and the risk management system under Article 10(2) must likewise be sustained by real-world data. The end point of PMS is therefore not the report itself. A PMS cycle only closes when its outputs trigger an update of the Performance Evaluation Report, the risk management file, or a change assessment. Building that one-way data flow with defined record templates is what turns PMS from a reporting obligation into a functioning safety system. When the linkage is documented and demonstrated, notified body audits and surveillance visits move noticeably faster, because every PMS output can be traced to a concrete downstream action rather than to a filed report.

4. Practical recommendations

1. Establish the PMS system documentation required by Article 78 and record its location within the QMS structure, as required by Article 10(8)(i), so auditors can trace it without ambiguity.
2. Draft the PMS plan under Article 79 and Article 83(1) with explicit data sources, metrics, thresholds, statistical methods, observation periods and responsible owners for each device or device group.
3. For Class A and Class B devices, define written triggers for updating the PMS Report; for Class C and Class D devices, maintain an annual PSUR calendar so updates never fall behind the yearly minimum.
4. Build a one-way data flow from PMS to the PER, the risk management file and change assessment, supported by standard record templates and defined responsibilities.
5. For legacy devices, mark the applicable scope of Chapter VII separately, following the approach set out in MDCG 2022-8, so the surveillance burden is neither underestimated nor duplicated.

5. Verification checklist

• □ The PMS system is established and integrated into the QMS (Article 78, Article 10(8)(i))
• □ The PMS plan defines methods and observation periods (Article 79, Article 83(1))
• □ The PMS Report for Class A and Class B devices is prepared and update triggers are set (Article 80)
• □ An annual PSUR mechanism is in place for Class C and Class D devices (Article 81)
• □ A channel exists for routing PMS outputs back to the PER and risk management (Article 56(6))
• □ The applicable scope of Chapter VII for legacy devices is documented separately (MDCG 2022-8)

Legal information verified as of 29 October 2026.

GRZAN supports IVD manufacturers placing products on the EU market under the IVDR with end-to-end post-market compliance: building Article 78 PMS systems and Article 79 PMS plans, preparing Article 80 PMS Reports and Article 81 PSURs, running vigilance and FSCA recall management, and designing PMPF and performance study follow-up programmes that stand up to notified body review. For assistance with post-market surveillance under the IVDR, contact info@grzanglobal.com.