Many PMS systems pass the audit but still fail to provide reliable insights for decision-making in day-to-day operations. We set up your PMS as an active and systematic management system: data sources, responsibilities, monitoring periods, and escalation pathways are seamlessly integrated—throughout the entire product life cycle.
300+ PMS projects · Medical Devices MDR · In-Vitro Diagnostics IVDRPMS is the proactive, systematic process of collecting and evaluating product and market data after a device has been placed on the market. The goal is to continuously monitor the safety, performance, and risk-benefit profile of medical devices and IVDs.
describes methods for data collection and analysis, threshold values, responsibilities, and update frequencies for post-market surveillance
PSUR for class IIa–III devices pursuant to MDR Article 86 and IVDR Article 81, and PMS report for class I devices pursuant to MDR Article 85 and IVDR Article 80
reporting and evaluation of serious incidents and safety corrective actions in accordance with MDR Art. 87 et seq. / IVDR Art. 82 et seq.
The MDR and IVDR require a wide range of interlinked plans and reports throughout the entire product life cycle. Some are subject to fixed deadlines, while others must be integrated into the cycle in a meaningful way, and data collection begins as early as the development phase. After CE marking, you enter an ongoing process of reporting and plan adjustments. This is exactly where our service concept comes in: We link these documents into a controlled cycle rather than treating them as isolated, standalone records.
| Class I | Class IIa / IIb / III | Class III & Implants |
| PMS Report | PSUR | + SSCP |
Unlike providers who treat PMS as a standalone document creation process, we coordinate strategic planning and effective implementation from a single source: the PMS plan, PMCF/PMPF, PSUR/PMS report, clinical evaluation/CER, and SSCP are interconnected elements of your technical documentation. We effectively integrate PMS activities with related processes such as pharmacovigilance, CAPA, and risk management, ensuring that insights from the market feed back into ongoing monitoring and improvements.
"A PMS system that not only passes audits but also works in day-to-day operations and supports real-world decision-making."
Post-Market Surveillance at MeteconThree problems that a PMS—designed as a management system — solves — and how we implement this for you in practice.
Data from service, pharmacovigilance, sales, and clinical operations are scattered—no consistent picture, no reliable conclusions.
For you: We consolidate data sources into an analyzable structure that makes conclusions clear.
Reports summarize PMS data, but reliable conclusions and follow-up actions are lacking.
For you: We anchor results and conclusions so that reports can be turned into decisions.
The results of PMS activities do not interrelate.
For you: We define a mechanism with triggers, thresholds, and escalation paths so that the need for action is identified early and in a transparent manner.
A PMS system requires clearly defined responsibilities, data sources, evaluation methods, and follow-up measures.
Metecon provides support in establishing a PMS process and implementing PMS plans to ensure that PMS activities are carried out in a traceable manner.
The PMS plan, PMS report, and PSUR must clearly document data sources, data collection and analysis methods, conclusions, and required actions. ISO/TR 20416 supports the practical planning of PMS processes, MDCG 2022-21 specifies the PSUR structure, and MDCG 2025-10 summarizes the PMS requirements under the MDR/IVDR.
PMS systematically collects and evaluates data from the marketing phase. Vigilance addresses reportable events and field safety corrective actions. PMCF and PMPF are data sources for PMS, but should be covered in greater detail on the respective Clinical Affairs pages.
Product-specific PMS plan in accordance with MDR Article 84 / IVDR Article 79 and MDR/IVDR Annex III: data sources, collection and analysis methods, thresholds, responsibilities, and update frequency, as well as an overarching PMS procedure as needed.
Periodic Safety Update Report in accordance with MDCG 2022-21: overview of PMS activities, data collection, and analysis results, including vigilance and trend reporting, as well as a summary of conclusions and any measures taken.
Vigilance Procedures Under the MDR/IVDR: assessment of reportable events, reporting deadlines, reporting channels, trend reports, and field safety corrective actions.
Statistical and Qualitative Trend Analysis: define thresholds, evaluate anomalies, and derive necessary actions in a transparent manner.
Structuring IMDRF codes for PMS and vigilance data: recoding existing data, implementation in the complaint management system, and analysis logic for PSURs/PMSRs in accordance with the internal data matrix (based, among other things, on MDCG 2022-21).
Ongoing services for data collection, trend analysis, and PMS/PSUR reporting—to expand manufacturers' capacity.
PMS Plan, PSUR, vigilance, and trend reporting in accordance with MDR Chapter VII, Annex III.
MDR Article 83 requires manufacturers to systematically collect, analyze, and continuously evaluate PMS data. Annex III describes the requirements for the PMS plan, PMS report, and PSUR in detail.
The PMS plan describes relevant data sources, data collection methods, analysis procedures, indicators and thresholds, responsibilities, and update frequencies in accordance with MDR Annex III.
Existing PMS plans from the MDD era or the early MDR phase often have structural gaps.
Metecon reviews existing PMS documentation for compliance with MDR, MDCG 2025-10, and MDCG 2022-21 requirements and prioritizes necessary adjustments.
Comprehensive PSUR including an analysis of relevant PMS data, pharmacovigilance information, summaries, and conclusions from postmarketing surveillance.
PSUR update at least every two years or as needed.
Class I products do not require a PSUR, but rather a PMS report that includes a regular summary of the results and conclusions from the PMS.
Assessment of reportable events, deadlines for serious incidents under MDR Article 87, and requirements for trend reports under MDR Article 88.
Metecon supports you in the structured implementation of the vigilance process and the traceable documentation of reportable trends.
Market data must be assessed for potential safety-related implications. MDR Article 83(4) describes the regulatory handling of relevant findings from PMS.
Metecon supports you in the structured evaluation and documentation of safety-related PMS information.
EUDAMED supports the structured collection and analysis of market data as part of PMS activities.
Metecon integrates relevant information into PMS activities.
Trend reports pursuant to MDR Article 88 concern statistically significant increases in the frequency or severity of incidents. PMS trend assessments also examine developments and anomalies in PMS data.
Metecon systematically identifies and evaluates relevant trends and parameters.
MMDCG 2023-3 clarifies key pharmacovigilance terms under the MDR, including serious incidents, field safety corrective actions, and reportable events.
Metecon supports you in applying the MDCG definitions in a manner that is compliant with regulatory requirements throughout the vigilance process.
Trend reporting involves the analysis and evaluation of anomalies, clusters, and relevant changes in PMS data. The goal is to provide a transparent assessment of safety-related developments and to determine whether reporting is required under MDR Article 88.
Metecon supports manufacturers in defining appropriate trend parameters and in the structured evaluation of relevant PMS data sources.
EUDAMED provides relevant vigilance and market information for PMS analysis in accordance with the MDR. Metecon supports the structured integration of relevant EUDAMED data into PMS processes.
Metecon: Query + Analysis
The FDA MAUDE database can provide additional safety and pharmacovigilance information. Metecon assists in developing a search strategy and subsequently evaluating the relevance of international PMS data sources.
Metecon: Research + Relevance Assessment
Relevant publications and safety information can be used as a PMS data source. Metecon provides support for research, assessment, and structured analysis.
Metecon: Research + Analysis
Complaints, claims, and market feedback provide important information for post-market surveillance. Metecon assists with the structured processing and analysis of relevant data.
Metecon: Coding + PSUR Integration
In-house vigilance reports and field safety corrective actions to evaluate the safety and performance of products within the PMS system.
Metecon: Integration into PMS-Plan
User surveys can provide additional insights into the safety and performance of products on the market. Metecon provides support with planning, implementation, and structured analysis.
Metecon: Planning + Analysis
Registry data can provide supplementary information on product performance and market behavior. Metecon assists with the evaluation and structured integration of relevant data sources.
Metecon: Data Retrieval + Analysis
Internal product and service data provide relevant information for post-market surveillance. Metecon assists with the structured analysis of existing data sources.
Metecon: QMS Integration
Both the MDR and MDCG 2022-21 describe the conditions under which multiple products may be grouped together in shared PMS documents (plans, reports). Key factors include comparable product characteristics, contexts of use, and an appropriate justification.
For you: Support with the regulatory assessment of suitable grouping strategies.
Current regulatory developments at the EU level include, among other things, PSUR update frequencies, software security incidents, and the use of EUDAMED.
For you: Monitoring of relevant changes and support in assessing potential impacts on existing PMS processes.
PMS is an ongoing process.
For you: Support with the regular collection, assessment, analysis, and updating of PMS reports and PSURs.
The PMS requirements under the IVDR correspond to the MDR requirements in many areas. Differences exist, in particular, with regard to IVD-specific data sources and the ongoing evaluation of analytical and clinical performance data.
PMS requirement for all manufacturers, PMS plan structure in accordance with IVDR Annex III, PSUR requirement for higher risk classes (C+D), PMS report for lower risk classes (A+B), vigilance obligations, and requirements for reporting trends are nearly identical word for word in the MDR and IVDR.
IVD-specific PMS data sources may include, for example, epidemiological databases.
Class C and class D IVDs require a PSUR at least once a year. For Class A and class B devices, the PMS report is updated whenever relevant new safety or performance information becomes available.
Performance data from PMPF data sources (e.g., interlaboratory tests), literature, user feedback, or other data sources can be incorporated into the post-market surveillance of IVDs.
Metecon supports manufacturers in the structured evaluation of relevant performance and safety data in accordance with the IVDR.
Class C and class D IVDs are subject to expanded PMS requirements, including regular PSUR updates and structured analysis of relevant performance and safety data.
Metecon supports manufacturers in the regulatory implementation of the PMS system for high-risk IVDs in accordance with the IVDR.
Julia Kudera, together with Sabine Schumann-Hahn, leads the Post-Market Surveillance team for medical device manufacturers. The team’s goal is to establish PMS as an ongoing control system: data sources, responsibilities, monitoring periods, and escalation pathways are integrated in such a way that risks and trends become apparent early on—and lead to effective decisions through vigilance, CAPA, and risk management.
"A PMS system that not only passes audits but also works in day-to-day operations and supports real-world decision-making—that’s what we’re designing your system to do."
Julia Kudera, Team Lead Post-Market Surveillance, Metecon
The PMS plan describes how and with which methods a manufacturer will collect and evaluate PMS data. The PMS report documents the results for class I devices. The PSUR is the more comprehensive safety report for class IIa through class III devices in accordance with MDCG 2022-21: It summarizes safety-related findings, including an updated benefit-risk assessment, PMCF/PMPF results, trends, and vigilance data, and uses this information to identify any necessary updates to the technical documentation.
For class III medical devices and implantable class IIb devices: at least once a year. Class IIa and non-implantable class IIb devices: at least once every two years. Class I devices require only a PMS report, not a PSUR. In addition, the report must be updated immediately whenever new safety-related information becomes available. For class C and class D IVD devices, a PSUR is prepared annually; for class A and class B devices, a PMS report is prepared as needed.
Yes, under the following conditions: The manufacturer must justify the grouping in its PMS documentation (e.g., the same manufacturing process, the same design, and the same intended use). The documents must clearly specify which products are included and which is the "leading device".
IMDRF Adverse Event Terminology is a standardized coding system for adverse events. The MDCG 2022-21 guideline recommends coding to enable comparable analysis across reporting periods. The most common challenge: Historical complaints and pharmacovigilance data have not yet been coded according to these codes. Metecon provides support for initial implementation and retroactive coding.
PMS is the proactive component: a systematic approach to actively and systematically collect, record, and analyze relevant data on a product's quality, performance, and safety throughout its entire life cycle. Vigilance is the reactive part: it focuses on the management and analysis of serious incidents and field safety corrective actions (FSCA), as well as the corresponding reporting.
The MDR and IVDR are structurally very similar with regard to the PMS system, but they differ primarily in the classification of products and the associated reporting requirements, as well as in the PMS activities related to PMPF for IVD devices and PMCF for medical devices.
Outsourcing post-market surveillance (PMS) is particularly advisable when a company does not have its own post-market surveillance structure, PMS activities are needed only for the initial setup, the regular preparation of PSURs can be handled more efficiently by an external provider, or the company does not intend to build up specialized expertise internally—such as for searching safety databases, conducting trend analyses, or selecting appropriate PMS activities.
MDR Article 83 stipulates that the PMS system must be maintained throughout the entire product life cycle. The PMS remains mandatory until the end of the product’s service life, as specified in the technical documentation, is reached. Therefore, the PMS and technical documentation must continue to be maintained even after sales have ended and must be available upon request. Metecon provides support in transitioning to a streamlined post-market strategy at the end of the product life cycle.
For importers under Article 13 of the MDR, the most relevant obligations regarding the PMS are those that involve systematically recording and forwarding market feedback (complaints/incidents) and supporting corrective actions. Importers are not manufacturers and are not required to create their own PMS documents; however, they may be required to provide structured data as part of the quality assurance agreement (QAA) with the manufacturer. Metecon provides support in drafting these QAA clauses and integrating the importer's data into the manufacturer’s PMS system.
PMCF & PMPF →
PMCF & PMPF as the Clinical Arm of the PMS System
Clinical Affairs →
Clinical Evaluation (CER) – PMS Update Interface
Risk Management →
Risk Management ISO 14971 – CAPA Based on PMS Findings
TechDoc →
Technical Documentation for MDR & IVDR
QMS →
QMS & ISO 13485 Auditing – PMS Integration
Regulatory Affairs →
Regulatory Affairs – Approval & Post-Market Activities
PMS Digitalization →
Structured Data & Digital PMS Processes
Start with a free initial consultation. Within a few days, you’ll receive a clear assessment—PMS plan, PSUR, vigilance SOP, or PMS grouping in accordance with MDCG 2025-10.
Your contact:
Dr. Caroline Arnold
Head of Sales
T: +49 621 123469-037
caroline.arnold@metecon.de
