What Is Post-Market Surveillance (PMS) Under MDR? A Starter Guide
Post-market surveillance under MDR is the ongoing system for collecting and acting on real-world device data. Here is what Articles 83-86 require and how startups actually build it.
Category
Post-Market Surveillance & Vigilance
44 in-depth guides in this cluster
MDR Articles 83-86: The Post-Market Surveillance Framework Explained
MDR Articles 83 to 86 define the post-market surveillance system, plan, report, and PSUR. Here is what each article requires and how they fit together.
The Post-Market Surveillance Plan: How to Write It Under MDR Annex III
MDR Annex III defines the contents of a PMS plan. Here is what must appear in it, how to structure it for a startup, and what auditors check.
The Post-Market Surveillance Report (PMSR) for Class I Devices
Class I devices require a PMS report under MDR Article 85. Here is what goes in it and how to keep it current without building infrastructure you do not need.
The Periodic Safety Update Report (PSUR) for Class IIa, IIb, and III Devices
The PSUR under MDR Article 86 is the periodic safety update for IIa, IIb, and III devices. Here is the structure, the frequency by class, and what Notified Bodies look for.
PMS Data Sources: Where to Find Post-Market Data for Your Startup's Device
MDR Annex III lists the PMS data sources you must consider. Here is what each one looks like for a startup with limited footprint.
Proactive vs. Reactive PMS: Building a System That Catches Issues Early
Reactive PMS waits for complaints. Proactive PMS goes looking for signals. MDR expects both. Here is how to build proactive methods into a startup PMS system.
Customer Complaint Handling Under MDR: A Process Guide for Startups
Complaint handling is where most PMS systems break down. Here is the process under MDR and EN ISO 13485 that actually catches safety signals early.
Trend Reporting Under MDR Article 88: When Statistical Increases Must Be Reported
MDR Article 88 requires manufacturers to report statistically significant increases in non-serious incidents or expected side-effects. Here is how to detect and report them.
How to Build a PMS System on a Startup Budget
A PMS system that runs without burning the team is achievable for a small MedTech company. Here is the lean PMS build that satisfies MDR Annex III.
PMS for Software as a Medical Device: Unique Monitoring Requirements
Post-market surveillance for SaMD has unique requirements: telemetry, version performance, cybersecurity events. Here is how to design it.
What Is Vigilance Under MDR? Understanding the Serious Incident Reporting System
Vigilance under MDR is the mandatory serious-incident reporting system. Here is what it covers, how it differs from PMS, and what startups must report.
MDR Articles 87-92: The Vigilance Reporting Framework for Manufacturers
MDR Articles 87 to 92 define the manufacturer vigilance obligations: serious incident reports, trend reports, field safety corrective actions, and the Eudamed flow.
Serious Incidents Under MDR: How to Determine If an Event Must Be Reported
A serious incident under MDR triggers mandatory reporting. Here is how to determine whether an event meets the threshold, and what to do once it does.
How to Report a Serious Incident to Your Competent Authority: Step-by-Step
When a serious incident is reportable, you have 15, 10, or 2 days depending on severity. Here is the step-by-step reporting process.
Vigilance Reporting Timelines Under MDR: The 15-Day and 2-Day Rules
MDR Article 87 sets three vigilance deadlines: 15 days for standard serious incidents, 10 days for death or unanticipated deterioration, and 2 days for public health threats.
Field Safety Corrective Actions (FSCAs) Under MDR: When and How to Act
A Field Safety Corrective Action under MDR is any manufacturer action taken to reduce risk on a device already on the market. Here is when to trigger one and how to execute it.
Field Safety Notices Under MDR: How to Communicate with Users and Patients
A Field Safety Notice is how you communicate safety corrective actions to users. MDR Article 2(69) defines it, MDCG 2023-3 Rev.2 shapes it. Here is how to write one.
Recalls Under MDR: The Process for Withdrawing a Device from the Market
A recall under MDR is an FSCA that withdraws a device from use or from the market. Here is the process, the reporting, and how startups should plan for the possibility.
The Relationship Between PMS, Vigilance, and CAPA Under MDR
PMS, vigilance, and CAPA are three interlocking MDR processes. Here is how they feed each other and what auditors check for integration.
Post-Market Clinical Follow-Up (PMCF) Under MDR: A Complete Guide for Startups
PMCF under MDR is the ongoing collection of clinical data after CE marking. Here is the complete guide: plan, execution, report, and the lifecycle loop.
How to Write a PMCF Plan Under MDR Annex XIV Part B
A PMCF plan under MDR Annex XIV Part B structures your post-market clinical follow-up. Here is what to include and how to keep it proportionate.
How to Write a PMCF Evaluation Report Under MDR
The PMCF evaluation report under MDR Annex XIV Part B summarises post-market clinical data. Here is the structure that satisfies auditors.
PMCF Study Design: Prospective Studies for Post-Market Data Collection
A PMCF study collects post-market clinical data on a CE-marked device. Here is how to design a prospective PMCF study that satisfies MDR Annex XIV Part B.
PMCF Surveys and Registries: Low-Cost Approaches for Startups
PMCF surveys and registries are low-cost ways to collect post-market clinical data. Here is when each fits and how to design them under MDR Annex XIV Part B.
When PMCF Is Not Required: Justifying the Exception Under MDR
PMCF is not always required under MDR. Here is when you can justify a no-PMCF position and what evidence the Notified Body expects.
PMCF for Software and AI/ML Devices: Continuous Performance Monitoring
PMCF for software and AI devices looks different from hardware PMCF. Here is how to design continuous performance monitoring that satisfies MDR Annex XIV Part B.
How PMS Feeds Back into Risk Management: Closing the Loop Under MDR
MDR requires PMS data to feed back into the risk file. Here is how the loop works under EN ISO 14971 and what auditors check for integration.
How PMS Data Updates Your Clinical Evaluation: The Lifecycle Approach
MDR requires PMS and PMCF data to update the clinical evaluation report on a lifecycle cadence. Here is how the CER-PMS loop actually closes.
PMS and Labeling Updates: When Post-Market Data Requires IFU Changes
When PMS data shows a new risk, the IFU has to change. Here is how to decide between an IFU update, an FSN, and an FSCA under MDR.
Market Surveillance by Competent Authorities: What Startups Should Expect
Competent Authorities perform market surveillance under MDR Articles 93-100. Here is what that means in practice and how startups should be prepared.
How to Handle a Market Surveillance Inspection as a Startup
A Competent Authority market surveillance inspection lands differently than an NB audit. Here is how to handle it without making the situation worse.
The Summary of Safety and Clinical Performance (SSCP) Under MDR Article 32
SSCP under MDR Article 32 is a public-facing safety and performance summary for implantables and Class III devices. Here is what it must contain and who reads it.
How to Write an SSCP for Class III and Implantable Devices
Write an SSCP for Class III and implantable devices under MDR Article 32: section-by-section template, lay summary rules, and NB validation steps.
PMS Tools and Software for Startups: Building an Efficient Monitoring System
PMS tools and software for MDR startups: the categories that matter, the build-vs-buy decision, and the lean stack that satisfies Annex III.
Using AI for Post-Market Surveillance: Automating Complaint Analysis and Trend Detection
AI can accelerate PMS by automating complaint triage, trend detection, and literature surveillance. Here is how to use it without losing the safety net.
The 8 Most Common PMS Mistakes Startups Make Under MDR
The eight most common post-market surveillance mistakes in MDR startup audits, each with the article it violates and how to fix it.
PMS for Multi-Market Devices: Coordinating Surveillance Across EU Member States
PMS for a device sold across multiple EU Member States needs coordination across competent authorities. Here is how to design it under MDR.
How to Demonstrate Continuous Compliance Through Effective PMS
Continuous compliance under MDR is demonstrated through PMS records that auditors can trace end to end. Here is how to make it visible.
PMS Reporting Checklist for Startups: Everything Due and When
The complete PMS reporting checklist for MedTech startups: what is due, when it is due, and which article mandates it, by device class.
MDR Risk Control Measures: The Three-Step Approach Using EN ISO 14971
The MDR risk control three-step EN ISO 14971 hierarchy: inherent safety by design, protective measures, information for safety. Why auditors challenge shortcuts.
Inherent Safety by Design: The First and Most Important Risk Control
Inherent safety by design medical device controls eliminate hazards rather than mitigate them. Tier 1 of EN ISO 14971 clause 7 and MDR Annex I ยง4, explained.
Protective Measures as Risk Controls: Guards, Alarms, and Interlocks
Protective measures medical device risk controls: guards, alarms, interlocks, fail-safes. Tier 2 of EN ISO 14971 clause 7 and when NBs accept them vs require tier 1.
IMDRF Adverse Event Terminology: Coding Feeds MDR Vigilance
IMDRF Adverse Event Terminology is how Eudamed codes vigilance data. Here is how to build the lookup into your complaint intake before you need it.