What is Post-Market Surveillance (PMS)?
Post-Market Surveillance (PMS), as defined in the MDR (EU 2017/745) and IVDR (EU 2017/746) regulations, is a systematic and proactive process of collecting and analyzing data regarding the quality, performance, safety, and effectiveness of a medical device or in vitro diagnostic device after it has been placed on the market and put into use. PMS is a key component of the manufacturer’s quality management system and is intended to ensure ongoing compliance with the essential requirements, as well as early detection of risks and non-conformities.
The obligation to establish a PMS system applies to every manufacturer of a medical device or IVD, regardless of the risk class. According to Article 83 of the MDR and Article 78 of the IVDR, the PMS system must be proportionate to the device’s class, complexity, clinical application, and target population. The implemented PMS system should enable the assessment of the benefit-risk ratio based on actual use in clinical conditions.
Studies conducted within Eudamed have shown that an effectively functioning PMS system can reduce the risk of serious incidents by up to 35% during the first year of device use. As noted by Dr. Jürgen Steinbach, medical regulatory expert: “The PMS system is not only a legal requirement – it is a key quality tool that enables earlier risk detection than passive systems.”
Manufacturer’s obligations in post-market surveillance
The manufacturer is responsible for designing, implementing, and maintaining the PMS system in accordance with current legal and technical requirements. This system should be documented, auditable, and reviewed periodically to ensure ongoing compliance with essential requirements and the protection of user and patient health.
Manufacturer responsibilities include:
- developing and regularly updating the PMS Plan in accordance with Article 84 MDR and Article 79 IVDR,
- proactively collecting and analyzing data from the market, scientific literature, databases, and competitor monitoring,
- preparing PMS reports for Class I devices or periodic PSURs (Periodic Safety Update Reports) for Class IIa, IIb, and III devices,
- initiating CAPA (Corrective and Preventive Actions) based on PMS and vigilance outcomes,
- continuously updating the technical documentation, including clinical evaluation (MDR) or performance evaluation (IVDR).
PMS Plan
The PMS Plan is a document describing the structure and mechanisms of the PMS system and forms an integral part of the technical documentation. According to Annex III of the MDR/IVDR, the PMS Plan must be proportionate to the device risk and relevant to the post-market phase.
Required elements of the PMS Plan include:
- methods for collecting, analyzing, and interpreting market data,
- performance and safety indicators (e.g., number of adverse events per 1,000 uses),
- description of mechanisms for integration with the vigilance system,
- trend assessment procedures and early warning algorithms.
PMS Report
The PMS Report and PSUR (Periodic Safety Update Report) are key documents for documenting and reporting the results of PMS activities.
For Class I devices, a PMS report must be available upon request. For Class IIa, IIb, and III devices, a periodic PSUR is required (at least every 2 years for Class IIa and annually for Class IIb and III), which must be available to the notified body and competent authority.
The PSUR includes:
- collection and trend analysis of PMS data,
- assessment of the benefit-risk ratio,
- recommendations for updating technical documentation and risk analysis,
- identification of necessary corrective actions or product withdrawal.
Post-Market Studies: PMCF and PMPF
Post-Market Clinical Follow-up (PMCF) and Post-Market Performance Follow-up (PMPF) are activities aimed at collecting additional clinical and user data after a device has been approved for market placement. These are required by Annex XIV of the MDR (PMCF) and Annex XIII of the IVDR (PMPF).
PMCF – Medical Devices
Typical PMCF methods include:
- prospective observational studies,
- patient registries (e.g., for implantable devices),
- analysis of real-world clinical practice data and PMCF reports.
PMPF – IVD Devices
PMPF is a systematic approach to evaluating IVD test performance under routine conditions. It is especially relevant for Class C and D devices and aims to confirm sensitivity, specificity, and repeatability of test results.
PMPF studies may include:
- data collection from routine laboratories,
- audits of test use across different populations,
- analysis of epidemiological data and false positive/negative trends.
Market Data Analysis System
The PMS system must include methods for collecting, analyzing, and validating market data to ensure its quality, timeliness, and representativeness.
Sources of data include:
- end-user complaints,
- incident reports submitted to competent authorities,
- scientific publications, systematic reviews, meta-analyses,
- data from device registries,
- results of internal audits.
Integration of PMS with Vigilance
Effective integration of PMS and vigilance enables early detection of potential hazards and implementation of corrective actions. These systems should be procedurally and technologically compatible, particularly in terms of:
- continuous monitoring of serious adverse events,
- reporting of serious incidents and FSCA actions to Eudamed,
- cooperation with the notified body in cases of significant clinical risks.
Updating Technical Documentation Based on PMS
Data and conclusions from PMS, PMCF, and PMPF must be consistently incorporated into the technical documentation and translated into specific product improvement actions.
This includes:
- updating the clinical evaluation (MDR) or performance evaluation (IVDR),
- review and modification of the risk analysis,
- changes to the instructions for use and labeling,
- notifying the notified body in case of significant changes.
How Pure Clinical Can Support Post-Market Surveillance
- Design and update of PMS Plans and PMCF/PMPF strategies in accordance with MDR and IVDR annexes,
- Support in the preparation and analysis of PSURs, PMS Reports, and update documentation,
- Organization of observational studies and patient registries under PMCF,
- Data quality assessment and integration of vigilance with PMS systems,
- Preparation of documentation for the notified body and competent authorities.
FAQ
Does the PMS Plan need to be approved by the notified body?
How long must PMS data be retained?
What is the difference between PMS and vigilance?