What documents does PMS produce under EU MDR?

For Class I devices: a PMS report (Article 85), updated when necessary. For Class IIa, IIb, and III: a PSUR (Article 86), updated at defined intervals (at least every 2 years for IIa, annually for IIb and III). Both draw on the PMS plan required by Article 84.

Is PMS required in the US?

There is no single 'PMS regulation' but the equivalent obligations exist through complaint handling (21 CFR 820.198), CAPA (820.100), MDR reporting (Part 803), and 522 post-market surveillance orders. QMSR aligns further with ISO 13485 clause 8.

How does PMS interact with PMCF?

Post-Market Clinical Follow-up (PMCF) is the clinical data collection component of PMS under MDR Annex XIV Part B. PMCF confirms safety and performance in the intended use, identifies previously unknown side effects, and supports benefit-risk over the device lifetime. Its outputs feed the PMS report or PSUR.

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Post-MarketPost-Market & Safety Startup LifecyclePMS

Post-Market Surveillance

Activities to monitor device safety and performance after market release.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed September 19, 2026

Definition

Post-Market Surveillance (PMS) comprises the systematic processes a manufacturer establishes to actively collect and review experience gained from devices placed on the market, in order to identify any need to apply corrective or preventive actions. Under the EU MDR (Articles 83 to 86) and IVDR (Articles 78 to 81), every manufacturer must run a PMS system proportionate to risk class, described in a PMS plan, with outputs in a PMS report or PSUR. In the US, PMS is spread across complaint handling, medical device reporting, corrections and removals and, for some devices, FDA-ordered section 522 studies. PMS data must feed back into risk management, clinical evaluation and CAPA.

What the regulation says

For MedTech manufacturers, Regulation (EU) 2017/745 (MDR), Articles 83 to 86 and Annex III, and Regulation (EU) 2017/746 (IVDR), Articles 78 to 81 and Annex III, require a documented, risk-proportionate PMS system and plan. Both Regulations were adopted on 5 April 2017; their general application dates were 26 May 2021 and 26 May 2022, respectively. Manufacturers must actively gather and analyse experience throughout device lifetimes. MDR Class I and IVDR Class A and B devices require PMS reports; other classes require periodic safety update reports (PSURs). MDR Class IIa PSURs are updated at least every two years; MDR Class IIb and III and IVDR Class C and D PSURs, at least annually. US requirements are distributed across FDA rules: medical device reporting under 21 CFR Part 803, corrections and removals under Part 806, and FDA-ordered surveillance under section 522 of the Federal Food, Drug, and Cosmetic Act and Part 822. The Quality Management System Regulation, effective 2 February 2026, amended Part 820, incorporating ISO 13485:2016 requirements, including complaint handling and corrective action. EU PMS findings must inform risk management, clinical or performance evaluation, and corrective and preventive action, rather than simply populate reports.

What this means in practice

PMS is required under EU MDR Articles 83-86 and IVDR Articles 78-81, and is embedded in FDA's Quality System Regulation (soon QMSR) through complaint handling (820.198), CAPA (820.100), and MDR reporting (Part 803). Under EU MDR, manufacturers must maintain a PMS plan proportionate to device risk (Article 84), covering active and reactive data collection: vigilance and serious incidents, trend reports (Article 88), user feedback, scientific literature, similar-device data, PMCF for Class IIa and above, and PMS reports (Class I) or PSURs (Class IIa+). Outputs feed the risk management file, technical documentation, clinical evaluation, and, where needed, corrective actions and field safety corrective actions (FSCA).

Examples

A Class IIb implantable device team runs quarterly PMS reviews aggregating complaints, PMCF data, and literature searches, updating the RMF and PSUR annually.
A Class IIa SaMD manufacturer maintains an automated pipeline that ingests support tickets, app store reviews, and adverse-event reports into a single PMS dashboard reviewed monthly.

Use cases

1 scenario

PMS plan for a connected insulin pen cap

Post-market team

The PMS plan defines complaint trending, app analytics review, literature monitoring, and a registry partnership. Inputs feed a PSUR every two years and a continuously updated risk file.

OutcomeAn emerging usability issue is detected within one quarter and fixed via a labeling change before it becomes a vigilance event.

Common pitfalls

•Confusing PMS (proactive, plan-driven) with vigilance (reactive, incident-driven). MDR Article 83 explicitly distinguishes them; you need both.
•Under-scoping PMS to complaints only. MDR expects trend analysis, literature review, similar-device data, and PMCF results as well.
•Missing the trend reporting obligation. MDR Article 88 requires reporting statistically significant increases in non-serious incidents or expected side effects.
•Treating PMS as separate from the RMF. PMS outputs must be linked to risk analysis updates and, where relevant, to CAPA.

Frequently asked questions

PMS is the systematic, proactive process of collecting and analyzing all post-market data. Vigilance is the specific reactive process for reporting serious incidents and field safety corrective actions (FSCA) to competent authorities. Vigilance is one input to PMS.

Cross-references

Follows

Comes after in a typical workflow or lifecycle.

510(k) Premarket Notification(510(k))

Grouped by theme

Editor's picks

· Hand-selected related concepts

Post-Market

Periodic Safety Update Report(PSUR)

Periodic EU MDR/IVDR report summarizing post-market surveillance findings.

Post-Market

Field Safety Corrective Action(FSCA)

Action taken to reduce a risk of serious deterioration in health associated with a device.

Post-Market

Medical Device Vigilance

Reporting and management of serious incidents and field safety corrective actions.

Quality & Risk

Corrective and Preventive Action(CAPA)

Systematic process to investigate and resolve quality issues and prevent recurrence.

Post-Market Mastery

· From this learning path

Post-Market

Medical Device Recall

Removal or correction of a marketed device that violates FDA law.

Post-Market

Medical Device Reporting (FDA)(MDR)

FDA mechanism for receiving reports of device-related deaths, serious injuries, and malfunctions.

Quality & Risk

Complaint Handling

Process for receiving, evaluating, and responding to device complaints.

Clinical & Trials

Real-World Evidence(RWE)

Clinical evidence regarding the usage and potential benefits or risks of a device derived from real-world data.

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Tier 1Binding law and standards· 1Tier 2Regulator guidance and consensus· 2

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EUR-Lex·1European Commission·1FDA·1

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Category: Post-Market
Acronym: PMS
Sources: 3
Use cases: 1
Updated: 9/19/2026

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Learn in 60 seconds

Activities to monitor device safety and performance after market release.

·Outputs feed the risk management file, technical documentation, clinical evaluation, and, where needed, corrective actions and field safety corrective actions (FSCA).
·Under the EU MDR (Articles 83 to 86) and IVDR (Articles 78 to 81), every manufacturer must run a PMS system proportionate to risk class, described in a PMS plan, with outputs in a PMS report or PSUR.
·In the US, PMS is spread across complaint handling, medical device reporting, corrections and removals and, for some devices, FDA-ordered section 522 studies.

Remember this

Watch out: Confusing PMS (proactive, plan-driven) with vigilance (reactive, incident-driven). MDR Article 83 explicitly distinguishes them; you need both.

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