Post Market Surveillance
Post Market Surveillance
Since May 26, 2022, the In Vitro Diagnostic Regulation (IVDR) requirements for Post Market Surveillance (PMS) have been applicable to all IVD devices. However, some manufacturers are not fully aware of the additional obligations imposed by the IVDR.
While PMS is not new for IVD manufacturers, the IVDR introduces more detailed and comprehensive requirements compared to the IVDD.
Key Aspects of Post-Market Surveillance (PMS) under the In Vitro Diagnostic Regulation (IVDR):
As a responsible manufacturer, establishing a comprehensive PMS system for each in vitro diagnostic (IVD) device is not only mandatory, but also critical to ensuring patient safety and product effectiveness.
To achieve this, integrate the PMS system seamlessly into your Quality Management System (QMS) and consider the following key aspects for data collection:
Thorough Reporting of Serious Incidents:
The PMS system must prioritize the collection and analysis of information concerning serious incidents. This includes diligently gathering data from Periodic Safety Update Reports (PSUR) and field safety corrective actions (FSCA). Swift reporting and thorough investigation of serious incidents enable early detection of potential safety risks and facilitate timely corrective actions.
Comprehensive Documentation of Non-Serious Incidents and Side- Effects:
Recognize the importance of documenting non-serious incidents and information related to undesirable side-effects. While these may not have immediate severe consequences, analyzing and documenting such incidents provide valuable insights into the overall safety profile and performance of the IVD device.
Data-Driven Trend Reporting:
Implement a systematic approach to collect and analyze data from trend reporting. This involves monitoring and evaluating patterns, recurring incidents, and user feedback. Trend reporting empowers manufacturers to proactively address emerging issues, implement improvements, and continuously enhance the safety and efficacy of their IVD devices.
Utilization of Specialist or Technical Literature, Databases, and Registers:
Manufacturers must proactively keep abreast of relevant specialist or technical literature, databases, and registers concerning IVD devices. Continuously updating and reviewing this information enables manufacturers to stay current with the latest advancements, safety concerns, and best practices in the industry.
Effective User Feedback and Complaints Handling:
Place high priority on collecting and analyzing information, including feedback and complaints, provided by users, distributors, and importers. Establish a robust mechanism to receive, process, and respond to user feedback promptly. This user-centric approach helps identify potential safety issues, meet user needs, and enhance overall product performance.
Evaluation of Publicly Available Information about Similar Devices: Manufacturers should conduct thorough assessments of publicly available information related to similar medical devices. This entails reviewing reports, studies, and safety alerts issued by regulatory bodies and other relevant sources. By learning from the experiences of similar devices, manufacturers can further improve their own devices’ safety and performance.
By diligently addressing these key aspects of PMS under the IVDR, manufacturers demonstrate their commitment to ensuring the safety and effectiveness of their IVD devices throughout their lifecycle. This proactive approach not only complies with regulatory requirements but also fosters trust among users, healthcare professionals, and regulatory authorities, ultimately contributing to a safer and more reliable IVD industry.
A proactive and systematic approach is essential to collect this data, using effective and appropriate methods and processes for data assessment, such as defining thresholds, indicators, and trending methods.
The data gathered through the PMS system serve various purposes, including:
- Updating the Benefit-Risk Determination, Design and Manufacturing Information, Instructions for Use and Labelling, Performance Evaluation (PE), and the Summary of Safety and Performance (SSP).
- Identifying the need for Corrective and Preventive Actions (CAPA) and
FSCAs, as well as opportunities for enhancing device usability, performance, and safety.
- Contributing to the PMS of other devices, where
Detecting and reporting trends.
To ensure compliance, the process and methods for data collection and analysis must be well-documented in the PMS plan, along with procedures for continuous updating of benefit-risk analysis and managing any identified events, such as CAPAs and FSCAs.
Where to Begin with PMS Implementation:
The initial step towards implementation is to integrate PMS into your QMS, ensuring that your procedures cover the PMS requirements described in Article 78-81, Annex III, and Annex XIII Part B of the IVDR. Establish links between PMS and Risk Management, CAPA, Performance Evaluation, and the Summary of Safety and Performance (SSP). Develop templates for required deliverables, including the PMS Plan, PMS Report (for Class A and B), and Periodic Safety Update Report (PSUR, for Class C and D).
For each device, you need a PMS Plan, including a PMPF Plan, or a justification if PMPF is not applicable to the device.
When creating the PMS Plan, define and justify similar devices based on the intended purpose of your device, and consider utilizing available PMS data. Include optional data sources such as production and post-production information or QC data.
Remember to collect both reactive data (e.g., feedback, complaints, and trend reporting) and proactive PMS data (e.g., through surveys, expert/focus groups, and PMPF).
Identify how you will collect each type of information, the frequency of data collection, who will assess the data, and whether additional infrastructure or resources are necessary.
Define indicators and threshold values for benefit-risk determination assessment, linking them to your device’s risk acceptability criteria and risk management policy.
Also, include methods for trend detection, investigation of complaints, and communication with Competent Authorities, Notified Bodies, Economic Operators, and users.
Required Deliverables and Frequency:
PMS results for Class A and B devices are reported in a PMS Report, while Class C and D devices require a PSUR. The PSUR must be updated annually, meaning the first version should be issued 12 months after receiving the IVDR certification.
For Class A and B devices, the frequency of updating the PMS Report should be specified in the PMS Plan and aligned with the device’s risk level, such as higher frequency for new technologies, those with significant patient impact, or new to the company.
It is crucial to note that for all devices, additional updates may be necessary in the case of serious events, significant trends in complaints, emerging risks, or previously unknown performance issues and limitations.
IVDD Legacy Devices:
For existing devices with an IVDD certificate or Declaration of Conformity, most PMS and PMPF requirements also apply. The recently published guidance MDCG-2022-8 on legacy devices clarifies exceptions for premarket requirements. For instance, updates are not needed for documents not required under the IVDD, such as the SSP, and the PER (for PMPF). PMS results for all legacy devices may be reported in a PMS report, and generating a PSUR is not mandatory, although manufacturers may voluntarily choose to do so. The PMS Plan should specify when and how often the PMS Report will be updated, aligning with the device’s risk level.
Conclusion:
Post-market surveillance is an ongoing process that utilizes post-market experience to update technical documentation. These requirements are now in effect and apply to the vast majority of IVD devices. Adhering to these regulations requires time and resources to meet the rigor expected by Notified Bodies. Failure to maintain PMS can jeopardize the validity of a certificate, making it essential for manufacturers to understand and allocate resources for PMS and PMPF appropriately.