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Regulatory & Compliance

Post-market surveillance.

We develop proactive PMS systems and clinical PMCF plans for medtech and IVD companies that meet the strict requirements of the MDR and IVDR and deliver real value.

Engineers analyze field reports and product safety data

What is Post-Market Surveillance (PMS)? Post-Market Surveillance, as defined in Articles 83–86 of the MDR, is the systematic monitoring of medical devices after they have been placed on the market. It includes PMS plans, PSURs, PMSR reports, trend reporting, and PMCF—with the aim of demonstrating safety and performance throughout the entire product lifecycle.

What PMS requirements does the MDR impose on manufacturers?

Under the MDR (EU) 2017/745, post-market surveillance is no longer an optional supplementary program, but a highly regulated mandatory requirement:

  • A dedicated PMS plan and the PSUR (Periodic Safety Update Report) are mandatory for almost all classes.
  • Post-market clinical follow-up (PMCF) activities are now explicitly required for Class IIa, IIb, and III devices.
  • Data from customer complaints, safety reports, and professional literature must be proactively and systematically aggregated.
  • Notified bodies scrutinize the accuracy of PMS documentation very closely during the certificate renewal process.
Have you already defined an up-to-date, MDR-compliant PMS and PMCF plan for each of your products?
Quality specialist enters field data into the logbook in a structured manner

Our PMS solutions for medtech and IVD.

We help you view market surveillance not as a burden, but as a proactive tool for managing product safety.

PMS Planning & Strategy
Development of product-specific PMS plans in accordance with MDR Annex III. We precisely define the relevant data sources, evaluation methods, and reporting intervals for each risk class.
PMCF Studies & Registries
Planning and operational management of PMCF activities (clinical trials, registry analyses, literature reviews) in accordance with MEDDEV 2.12/2 and their integration into the clinical evaluation.
PSUR & Signal Detection
Professional preparation of Periodic Safety Update Reports (PSURs) and SSCP documents. We implement methods for complaint trending and signal detection based on field data.
PMS System Structure & QMS
Full implementation of PMS processes into your existing QMS—including the definition of interfaces with vigilance, CAPA, and risk management, as well as training for your employees.

How does ENTOURAGE set up your PMS system?

From the initial assessment to ongoing reporting—in 5 phases.

01

PMS Assessment

Evaluate existing PMS activities. Identify data sources and prioritize gaps.

02

PMS Plan

Create product-specific PMS plans: data sources, methods, intervals, responsibilities.

03

PSUR/PMSR

Prepare Periodic Safety Update Reports (Class IIb/III) and Post-Market Surveillance Reports (Class I/IIa).

04

Trend Reporting

Develop a systematic trend-reporting system based on complaints, pharmacovigilance data, and literature data.

05

PMCF Integration

Integrate PMCF activities into the PMS cycle. Plan for proactive data generation.

PMS
“PMS is the regulatory early warning system. Those who treat it as a mere formality miss the opportunity to identify product issues before they lead to recalls.”
PMS & Vigilance Team, ENTOURAGE

Frequently Asked Questions About Post-Market Surveillance.

What is the difference between PMS and vigilance?
PMS is proactive: It involves the systematic collection and analysis of field data to monitor safety. Vigilance is reactive: It involves the mandatory reporting of specific, serious incidents to regulatory authorities.
What exactly is a PMCF plan?
A PMCF plan sets out in detail how clinical data will be systematically collected after market launch (e.g., through studies or surveys). This is a legal requirement for all Class IIa, IIb, and III devices.
How often must a PSUR be updated?
For Class III and implantable devices, the PSUR must be updated annually. For Class IIa and IIb devices, this must be done every two years. For Class I devices, a summary report (PMS report) is sufficient upon request.
What data is included in the PMS analysis?
According to MDR Annex XIV, data sources include, among others: complaints, vigilance cases, field safety corrective actions (FSCA), registry data, systematic reviews of the scientific literature, as well as feedback from user surveys.
How often must a PSUR be submitted?
For Class III devices and implants: annually. For Class IIb devices: at least every two years. For Class I/IIa devices, a PMSR is prepared instead of a PSUR—at least every five years.
What is the difference between PMS and vigilance?
PMS refers to proactive, systematic monitoring (PMS plans, PSURs, trend reporting). Pharmacovigilance refers to the mandatory reporting of serious adverse events (SAEs, FSCA). Both are components of the post-market system.

Additional expertise in medical compliance.

Expertise

Medical Device Vigilance

Reporting requirements, deadlines, and the reactive system under the MDR.

 Expertise

Complaint Management

Complaint management as the most important PMS database.

 Expertise

Risk Management

ISO 14971 evaluation as the basis for market approval.

Comply with the post-market obligations of the MDR.

Simply handling complaints is no longer enough. We establish proactive PMCF processes for you that will impress auditors and demonstrate your product safety over the long term.

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