🏛️REGULATORY CONTEXT
This guide defines the framework for the Post-Market Surveillance (PMS) system applicable to medical devices (MDs) and in vitro diagnostic medical devices (IVDMDs) and specifies the expectations for manufacturers regarding the implementation of the PMS system and plan, the key activities to be carried out, and their integration into the Quality Management System (QMS) in accordance with the requirements of the Regulations.
PMS is an ongoing regulatory requirement designed to ensure that devices remain safe, effective, and compliant throughout their lifecycle.
The guide specifies that it is not limited to passively collecting complaints, but is based on a proactive, systematic, and documented approach designed to leverage real-world experience with the devices to inform, among other things, risk management, clinical or performance evaluation, and vigilance.
🔍ANALYSIS
Scope of Application
This guide applies to all DM/DMDIVs, regardless of class.
Its main objectives are as follows:
- describe the PMS system required by the Regulations,
- clarify the content and role of the PMS plan,
- outline the key activities to be carried out,
- Clarify the interactions between the PMS and other QMS processes.
The guide explicitly excludes:
- the detailed description of the PSUR (covered by MDCG 2022-21),
- the specific requirements applicable to devices manufactured and used in-house by healthcare facilities (“in-house” devices).
The PMS system required by the Regulations
General Obligations
Manufacturers must plan, establish, document, implement, maintain, and update a PMS system that is proportionate to the risk class and the type of device.
This system should enable:
- the active and systematic collection of data on quality, performance, and safety,
- the analysis of this data over the entire lifespan of the device,
- the formulation of well-supported conclusions,
- Identifying and tracking corrective and preventive actions.
An overview of the PMS requirements set forth in the DM and DMDIV Regulations is provided in Appendix 1 of the guide.
Specific Requirements for Custom-Made Devices (RDM)
The guide notes that custom-made devices are not exempt from PMS requirements. Manufacturers must:
- document the experience gained during the post-production phase,
- implement a PMCF plan,
- Report serious incidents and safety corrective actions in accordance with Article 87 of the RDM.
For custom-made Class I devices, a PMS report is required, while for Classes IIa, IIb, and III, a PSUR is mandatory.
The PMS Plan
The PMS plan is the central component of the PMS system and forms part of the technical documentation (Articles 84 RDM/79 RDMDIV).
In particular, it must describe:
- the covered programs and their scope,
- proactive methods for collecting post-market data,
- analytical methods appropriate for the level of risk,
- the indicators and thresholds for reassessing the benefit-risk ratio,
- procedures for managing complaints, incidents, and trends,
- the procedures for communicating with the competent authorities and notified bodies,
- the inclusion of the PMCF or PMPF, or justification for their inapplicability.
Table 1 in the guide provides an overview of the elements that must be included in the plan. It also details methods and processes for evaluating the collected data, along with explanations and examples of these methods.
PMS’s Main Activities
Identification of Data Sources
Manufacturers must identify relevant data sources such as:
- serious and non-serious incidents,
- user complaints and returns,
- scientific literature and databases,
- public information on similar programs,
- data from the PMCF/PMPF.
The quality and reliability of the data must be assessed before any analysis is conducted.
Table 2 describes the information that must be collected and how it should be used.
Data Collection
Data collection begins as soon as the product is placed on the market and is based on documented processes for receiving, recording, and evaluating relevant information.
Data Analysis
The data must be analyzed in light of the objectives of the PMS plan to confirm performance, safety, and compliance with the state of the art.
Conclusions and Related Actions
The findings from the PMS must be documented in a PMS report or a PSUR and, where appropriate, lead to corrective, preventive, or safety actions.
Consequently, a review of the PMS plan may be necessary to determine the level of activity required for the next PMS cycle, taking into account, in particular, the device category, historical data, similar products, and PMCF/PMPF requirements.
Interactions with Other QMS Processes
The guide details the requirement to use PMS data for:
- update risk management and the risk-benefit analysis,
- update the clinical or performance evaluation,
- update the IFU, labeling, technical documentation, and, if applicable, the SS(C)P,
- Identify the needs of CAPA and FSCA, as well as the requirements for reporting trends,
- identify opportunities to improve the usability, performance, and safety of devices,
- contribute to the PMS of other devices from the manufacturer.
Table 3 in this chapter of the guide provides an overview of potential activities to consider.
Appendix 2 of the guide provides examples illustrating the various elements of a PMS system as well as its interactions with other key components of the QMS.
In conclusion, this guide clarifies the expectations regarding the operational implementation of the PMS and highlights its central role in managing the device lifecycle as a tool for risk management, regulatory compliance, and continuous improvement.
🎯Impact on Manufacturers
– Implement a proactive PMS that is integrated into the QMS, consistent with risk management, clinical or performance evaluation, and vigilance.
– Have a proportionate and well-documented PMS plan that covers data collection and analysis methods, as well as indicators for monitoring the benefit-risk ratio.
– Ensure the traceability of analyses and decisions, particularly through PMS or PSUR reports, and, if necessary, initiate corrective and preventive actions (CAPA) or safety corrective actions (FSCA).