The post-market surveillance plan, abbreviated as PMS plan, is the document by which a manufacturer demonstrates compliance with the system obligation for post-market surveillance. Article 84 of Regulation (EU) 2017/745 requires that the system under Article 83 be based on such a plan and refers to Annex III Section 1.1 for its requirements. For products that are not custom-made devices, the plan forms part of the technical documentation under Annex II. While the entry on post-market surveillance under MDR describes the system and its operation, this entry deals exclusively with the mandatory content of the plan document and its placement within the documentation.
Information to be collected under Annex III point (a)
The plan must describe the collection and use of available information, in particular information on serious incidents including data from periodic safety update reports and on field safety corrective actions, records of non-serious incidents and data on adverse side effects, information on trend reporting, relevant specialist or technical literature, databases and registers, information transmitted by users, distributors and importers including feedback and complaints, and publicly available information on similar medical devices.
The list constitutes a minimum catalogue. For each source, the plan should specify who evaluates it, at what intervals, using which search strategy, and how the results are documented; a plan that merely names sources is regularly criticized in audits.
Mandatory content under Annex III point (b)
The plan includes at least a proactive and systematic procedure for collecting the specified information that enables proper characterization of product performance and comparison with similar products on the market. In addition, it includes effective and appropriate methods and processes for evaluating the collected data, as well as suitable indicators and threshold values to be used in the continuous reassessment of the benefit-risk analysis and risk management.
Further requirements include methods and tools for examining complaints and analyzing market-related experience, methods and protocols for handling incidents subject to trend reporting including the methodology for determining statistically significant increases and the observation period, methods and protocols for communication with authorities, Notified Bodies, economic operators and users, references to procedures for fulfilling the obligations under Articles 83, 84 and 86, systematic procedures for identifying and initiating appropriate measures including corrective actions, and effective tools for identifying affected products.
The post-market clinical follow-up plan as a component
The final item in the catalogue requires a post-market clinical follow-up plan in accordance with Annex XIV Part B or a justification as to why such follow-up is not applicable. The post-market surveillance plan is thus the overarching document into which the plan described in the entry on Post-Market Clinical Follow-up is embedded. The justification for waiving follow-up must demonstrate, on a product- and risk-specific basis, that no open clinical questions exist, and is subject to critical review.
Placement, updating and approval
For all products except custom-made devices, the plan forms part of the technical documentation under Annex II; together with the reports under Articles 85 and 86, it constitutes the technical documentation on post-market surveillance under Annex III. For custom-made devices, the periodic safety update report forms part of the documentation under Annex XIII Section 2.
As a component of the technical documentation, the plan is subject to document control: it is versioned, approved and must be adapted when the risk profile, intended purpose or data situation changes. Threshold values that never trigger or trigger constantly must be revised with justification.
Distinction from report, clinical evaluation plan and risk management plan
The post-market surveillance plan defines what will be collected in the future and how it will be evaluated; the post-market surveillance report and the periodically updated periodic safety update report document the results of a completed period. The two must not be merged, as otherwise it is no longer verifiable whether the methodology was defined in advance.
The clinical evaluation plan under Annex XIV Part A describes the evidence strategy, the risk management plan governs the control of hazards. The post-market surveillance plan connects both through data flows and trigger criteria.
Relevance for clinical trials
For sponsors and manufacturers, the post-market surveillance plan is often the point at which the need for a post-market study first becomes formally visible. Indicators and threshold values in the plan determine when a signal is considered to require clarification, and the post-market clinical follow-up embedded within it translates this clarification into a methodologically described project with research question, endpoints, sample size considerations and analysis plan.
Equally important is the feedback loop: results from ongoing studies change the data situation and thus the appropriateness of the originally selected indicators. Full-service CROs such as Mediconomics support manufacturers in coordinating plan content, study protocols and reporting cycles so that the required evidence is generated without duplication of effort and without contradictions between documents.
Frequently Asked Questions (FAQ)
Does each product require its own post-market surveillance plan?
The obligation is product-related but can be fulfilled for product families in a single document, provided that the product-specific indicators, threshold values and data sources remain identifiable and the assignment to the affected Basic UDI-DI is documented.
How often must the plan be updated?
The Regulation does not specify an interval. Event-driven updating is mandatory; regular review as part of management review is common practice and expected by Notified Bodies.
Does the obligation also apply to Class I products?
Yes. Manufacturers of Class I products also require a plan under Article 84 and Annex III Section 1.1; they report the results in a post-market surveillance report under Article 85.
Regulatory References
- Regulation (EU) 2017/745, Article 84 — Post-market surveillance plan
- Regulation (EU) 2017/745, Annex III Section 1.1 points (a) and (b) — Mandatory content of the plan
- Regulation (EU) 2017/745, Article 88 — Trend reporting and methodology to be defined in the plan
- Regulation (EU) 2017/745, Annex XIV Part B — Post-market clinical follow-up plan
- Regulation (EU) 2017/745, Annex II and Annex XIII Section 2 — Placement in the technical documentation
