Post-Market Surveillance

Overview

Regulatory approval is not the end of the compliance journey, it is the beginning of a continuous obligation. Once your medical device is on the market, you must actively monitor its performance, collect and evaluate real-world data, report adverse events, and update your technical documentation to reflect current evidence. This is the domain of Post-Market Surveillance (PMS).

Under the EU Medical Device Regulation (MDR 2017/745), PMS is a legal requirement for all device classes. It is not a passive activity but a proactive, systematic process that generates the data needed to confirm safety and performance throughout the device lifecycle. Failure to maintain an effective PMS system is one of the most common causes of Notified Body nonconformities, certificate suspensions, and regulatory action.

At Veritas Quality Solutions, we help manufacturers design, implement, and maintain robust PMS systems that satisfy MDR requirements, FDA expectations, and the surveillance obligations of other major markets. Our services cover vigilance reporting, Post-Market Clinical Follow-Up (PMCF), Periodic Safety Update Reports (PSURs), and the integration of post-market data into your clinical evaluation and risk management processes.

Understanding Post-Market Surveillance Under EU MDR

What MDR Requires

The EU MDR establishes a comprehensive post-market framework built on several interconnected elements:

The PMS Plan

Every manufacturer must prepare a PMS plan for each device (or device family). The plan defines the methodology for proactively collecting and evaluating data, including:

Data sources to be used (complaints, returns, literature, registries, user feedback, service records)

Methods for evaluating the collected data

Criteria for determining when action is required

Procedures for investigating complaints and analysing trends

Interfaces with corrective and preventive action (CAPA) and risk management

The PMSR and PSUR

For Class I devices: A Post-Market Surveillance Report (PMSR) is required. For Class I devices, the PMSR must be prepared and made available to the Notified Body (where applicable) and competent authorities upon request. The PMSR must be updated when necessary and at least every two years.

For Class IIa, IIb, and III devices: A Periodic Safety Update Report (PSUR) is required. The PSUR must be prepared for each device and, where relevant, each category or group of devices. The frequency of PSUR preparation depends on device class:

For Class III devices and Class IIb implantable devices, the PSUR must be submitted to the Notified Body, which reviews it and adds its assessment to the report.

Post-Market Clinical Follow-Up (PMCF)

What is PMCF?

PMCF is a continuous process that updates the clinical evaluation of a device throughout its expected lifetime. It is a specific type of post-market surveillance activity that proactively collects and evaluates clinical data from the use of a device in the post-market phase.

Under MDR Annex XIV Part B, PMCF is required for all devices. The purpose of PMCF is to:

Confirm the safety and performance of the device throughout its expected lifetime

Identify previously unknown risks or contraindications

Identify and analyse emergent risks based on factual evidence

Ensure the continued acceptability of the benefit-risk ratio

Identify possible systematic misuse or off-label use of the device

The PMCF Plan

A PMCF plan is a mandatory document that specifies the methods and procedures used to proactively collect and evaluate clinical data. The plan must include:

General methods and procedures: The specific methods and procedures to be applied, such as literature reviews, registries, clinical investigations, or user surveys

Rationale for PMCF: Justification for the chosen methods, referencing the device's risk profile and clinical claims

Specific objectives: Clear, measurable objectives for the PMCF activities

Evaluation methodology: How the collected data will be analysed and evaluated

Timelines: Schedule for PMCF activities and reporting

Integration: How PMCF results will feed into the clinical evaluation, risk management, and PMS processes

The PMCF Evaluation Report

The PMCF Evaluation Report presents the results and conclusions of the PMCF activities. It must:

Analyse the clinical data collected through PMCF

Assess whether the clinical evidence remains sufficient to demonstrate safety and performance

Confirm whether the benefit-risk profile remains acceptable

Identify any need for updates to the clinical evaluation, risk management, or other technical documentation

Feed into the PMSR or PSUR, as applicable

PMCF Methods

Depending on the device, its risk class, and its clinical claims, PMCF may involve one or more of the following:

Literature reviews: Systematic reviews of published clinical data on the device, equivalent devices, or the clinical condition

Registries: Participation in or analysis of device or disease registries

Clinical investigations: Post-market clinical performance studies

User surveys: Structured collection of feedback from healthcare professionals and patients

Complaint and service data analysis: Systematic review of field data

Case series: Collection of clinical experiences from clinical centres

Vigilance and Incident Reporting

MDR Vigilance Requirements

Under MDR Articles 87–92, manufacturers must report serious incidents and field safety corrective actions (FSCAs) to the relevant competent authorities. Key obligations include:

Serious Incident Reporting:A serious incident is any incident that directly or indirectly led, might have led, or might lead to:

The death of a patient, user, or other person

The temporary or permanent serious deterioration of a patient's, user's, or other person's state of health

A serious public health threat

Manufacturers must report serious incidents immediately after establishing a causal relationship, or reasonably possible causal relationship, between the incident and the device. Reporting deadlines depend on the severity of the incident:

Field Safety Corrective Actions:Any FSCA taken to reduce the risk of death or serious deterioration of health must be reported to the competent authority of the Member State where the FSCA is undertaken. The report must include the reason for the FSCA, the affected devices, and the actions taken.

FDA Medical Device Reporting (MDR)

In the United States, manufacturers must comply with FDA Medical Device Reporting requirements under 21 CFR Part 803. Reports must be submitted for:

Deaths: within 30 calendar days

Serious injuries: within 30 calendar days

Malfunctions that would likely cause or contribute to a death or serious injury if the malfunction were to recur: within 30 calendar days

Certain events requiring 5-day reports

Trending and Signal Detection

Effective vigilance is not limited to individual incident reporting. It requires active trending and signal detection to identify patterns that may indicate a systemic issue. We help you establish:

Complaint trending: Statistical analysis of complaint data to identify increasing trends or clusters

Signal detection: Systematic review of field data, literature, and regulatory databases to identify emerging safety signals

CAPA linkage: Integration of vigilance data into the CAPA system to ensure that identified issues are investigated and addressed

Other Major Market PMS Requirements

United States (FDA)

FDA requires manufacturers to maintain a post-market surveillance system as part of the QMSR. For devices subject to post-market surveillance studies under 21 CFR Part 822, manufacturers must conduct and report on these studies. FDA also requires:

Medical Device Reporting (21 CFR Part 803)

Corrections and Removals reporting (21 CFR Part 806)

Annual reports for PMA devices (21 CFR Part 814)

Post-Approval Studies for certain PMA devices

Saudi Arabia (SFDA)

The SFDA requires manufacturers to implement post-market surveillance, including vigilance reporting and periodic safety update reports. The SFDA's requirements align with international standards, including reporting of adverse events and field safety corrective actions.

Brazil (ANVISA)

ANVISA requires post-market surveillance through the Technovigilance system. Manufacturers must report adverse events and technical complaints, and must conduct post-market surveillance activities in accordance with ANVISA resolutions.

Australia (TGA)

The TGA requires manufacturers to have a post-market surveillance system, including complaint handling, adverse event reporting, and periodic safety reporting. The TGA also conducts post-market reviews of devices.

UK (MHRA)

The MHRA requires manufacturers to maintain post-market surveillance and report adverse incidents. The UK's post-market requirements largely mirror MDR obligations, including vigilance reporting and PMCF.

China (NMPA)

NMPA requires post-market surveillance and adverse event reporting. Manufacturers must establish a post-market surveillance system and report adverse events through the NMPA's adverse event monitoring system.

Our Post-Market Surveillance Services

1. PMS System Design and Implementation

We help you design and implement a PMS system that satisfies MDR and other market requirements.

What We Deliver:

PMS Plan development tailored to your device and risk class

Data collection methodology and tools

Complaint handling and trending procedures

Vigilance reporting procedures

Integration with CAPA and risk management

Roles and responsibilities definition

2. PMS Plan and PMSR/PSUR Preparation

We prepare PMS plans, Post-Market Surveillance Reports (PMSRs) for Class I devices, and Periodic Safety Update Reports (PSURs) for Class IIa, IIb, and III devices.

What We Do:

Prepare PMS plans in accordance with MDR Annex III

Prepare PMSRs for Class I devices

Prepare PSURs for Class IIa, IIb, and III devices

Update PSURs at required frequencies

Coordinate PSUR submission to Notified Bodies

3. PMCF Plan and Evaluation Report

We prepare PMCF plans and PMCF Evaluation Reports in accordance with MDR Annex XIV Part B.

What We Do:

Develop PMCF plans with clear objectives and methods

Design PMCF activities (literature reviews, registries, surveys, clinical investigations)

Prepare PMCF Evaluation Reports

Integrate PMCF results into the clinical evaluation and risk management

Support PMCF study design and execution

4. Vigilance Reporting Support

We assist with vigilance reporting, including serious incident reporting and field safety corrective actions.

What We Do:

Establish vigilance reporting procedures

Assess incidents for reportability

Prepare and submit vigilance reports

Prepare Field Safety Notices (FSNs)

Manage communication with competent authorities

Support recall and FSCA activities

5. Complaint Handling and Trending

We help you establish effective complaint handling and trending systems.

What We Do:

Develop complaint handling procedures

Implement complaint trending and analysis

Identify signals and trends

Link complaint data to CAPA and risk management

Prepare trend reports for management review

6. Post-Market Data Integration

We help you integrate post-market data into your clinical evaluation, risk management, and technical documentation.

What We Do:

Integrate PMS data into the Clinical Evaluation Report

Update risk management files based on post-market data

Update technical documentation as required

Support regulatory submissions for changes

7. Audit Support and Inspection Readiness

We help you prepare for audits and inspections of your PMS system.

What We Do:

Conduct internal audits of the PMS system

Prepare for Notified Body and regulatory inspections

Address findings related to PMS

Implement corrective actions

Common PMS Deficiencies We Help You Avoid

Based on our experience and regulatory guidance, the most common PMS deficiencies include:

Inadequate PMS Plan: Plans that lack specific methods, objectives, or timelines, or that are generic rather than device-specific

Insufficient Data Collection: Failure to actively collect post-market data from all relevant sources

Poor Trending and Analysis: Inadequate analysis of complaint and vigilance data to identify trends and signals

Late or Incomplete Vigilance Reporting: Failure to report serious incidents within required timeframes

Missing PSURs or PMSRs: Failure to prepare and update required reports

PMCF Not Conducted: Failure to implement PMCF activities or to document their results

Lack of Integration: Failure to integrate PMS and PMCF data into clinical evaluation and risk management

Weak CAPA Linkage: Failure to link PMS findings to corrective and preventive actions

Why Choose Veritas Quality Solutions

Regulatory Expertise

Our team has deep experience with MDR post-market requirements, FDA post-market obligations, and the surveillance requirements of major markets worldwide. We understand what regulators expect and how to build systems that satisfy them.

Practical Approach

We do not provide generic templates. Every PMS system we design is tailored to your device, its risk profile, and your target markets. We focus on building systems that are practical, effective, and sustainable.

End-to-End Support

From PMS plan development through to vigilance reporting and PMCF execution, we support the entire post-market lifecycle. Whether you need a complete PMS system or targeted support for a specific obligation, we adapt to your needs.

Proven Track Record

We have supported manufacturers across device classes and therapeutic areas in maintaining post-market compliance and responding to regulatory scrutiny.

Get Started

Whether you are establishing a PMS system for the first time, updating your PMS documentation, or preparing for a Notified Body audit, Veritas Quality Solutions is here to help.

Veritas Quality Solutions, Your Partner in Quality Assurance