Post-Market Surveillance (PMS) and Post-Market Performance Follow-Up (PMPF) under In Vitro Diagnostics Regulation (EU) 2017/746 (EU IVDR)
General Background
Post-Market Surveillance
Post-market surveillance (PMS) under the In Vitro Diagnostic Regulation (EU IVDR) is the ongoing process of monitoring the safety and performance of in vitro diagnostic medical devices (IVDs) after they have been placed on the market in the European Union.
Under the IVDR, manufacturers are responsible for conducting post-market surveillance activities to actively and systematically gather, record and analyze relevant data on the quality, performance and safety of a device throughout the entire device lifetime.
The manufacturer should address the collection and utilization of relevant sources including:
- Serious incidents, PSURs, and field safety corrective actions
- Non-serious incidents and undesirable side-effects
- Information from trend reporting
- Specialist or technical literature, databases and/or registers
- Feedback and complaints
- Publicly available information about similar medical devices
Manufacturers shall collect and analyze the data, including feedback from patients, healthcare professionals, and clinical investigations, to identify any potential safety issues or performance problems.
Additionally, based on the Article 78(3) of EU IVDR, the gathered data should be used:
- To update the benefit-risk determination and to improve the risk management.
- To update the design and manufacturing information, the instructions for use and the labelling.
- To update the performance evaluation.
- To update the summary of safety and performance.
- For the identification of needs for preventive, corrective or field safety corrective action.
- For the identification of options to improve the usability, performance and safety of the device.
- When relevant, to contribute to the post-market surveillance of other devices
- To detect and report trends.
Manufacturers must update their risk management system based on the information collected during PMS activities.
If any safety or performance issues are identified during PMS activities, manufacturers must take appropriate corrective and preventive actions to address the issue and prevent it from happening again.
Manufacturers must report any serious incidents or safety issues to the relevant regulatory authorities, including the European Database on Medical Devices (EUDAMED).
The EU IVDR places a greater emphasis on PMS activities compared to the previous IVD Directive, as it requires manufacturers to conduct PMS activities throughout the entire lifecycle of the device, rather than just after it has been placed on the market.
Support & Training
Contact AKRA TEAM for support, hands on implementation services and personalized training by experts with key competencies in the areas listed below.
General Background
Post-Market Performance Follow-up
The EU IVDR requires manufacturers to conduct Post-Market Performance Follow-up (PMPF) activities. PMPF is an ongoing process that involves the collection, analysis, and evaluation of data related to the performance of in vitro diagnostic medical devices (IVDs) after they have been placed on the market.
PMPF is a continuous process that involves the collection, analysis, and evaluation of performance and relevant scientific data from the use of a device which bears the CE marking and is placed on the market or put into service within its intended purpose. This data is used to confirm the safety and performance of the device in real-world conditions and to identify any potential issues or risks associated with the device that may not have been identified during the pre-market clinical evaluation. PMPF is a continuous process that updates the clinical evaluation and should be addressed in the post-market surveillance plan and conduced according to the PMPF plan per Annex XIII Part B of EU IVDR.
Manufacturers must ensure that appropriate methods, procedures and product specific appropriate triggers for proactively collecting and evaluating safety, performance and scientific data with the aim of conducting PMPF are included in the PMPF plan.
The key steps involved in PMPF under the EU IVDR include:
- Developing a PMPF plan: The PMPF plan should describe the methods and procedures for collecting, analyzing, and evaluating data about the IVD, as well as the specific objectives of the PMPF study.
- Conducting the PMPF study: The PMPF study involves collecting data from a range of sources, including post-market surveillance data, clinical investigations, and literature reviews.
- Evaluating the PMPF data: The PMPF data should be analyzed and evaluated to identify any potential issues or risks associated with the IVD and to verify its ongoing safety and performance.
- Updating the performance evaluation report: The PMPF data should be used to update the performance evaluation report for the IVD, which is used to demonstrate compliance with the EU IVDR requirements.
In some cases, PMPF can be justified as not required (Annex III 1b and Annex XIII Part B 8). If PMPF is not deemed appropriate for a specific IVD, a justification should be provided and documented within the performance evaluation report.
PMPF is a critical component of the EU IVDR that helps to ensure the ongoing safety and effectiveness of IVDs in real-world conditions. It is an important aspect of EU IVDR compliance, and manufacturers must have a robust PMPF plan in place for their devices.
Support & Training
Contact AKRA TEAM for support, hands on implementation services and personalized training by experts with key competencies in the areas listed below.
Key points
Our Services
Training
AKRA TEAM provides training regarding general Post-Market Surveillance and/or Post-Market Performance Follow-up as well as specific topics regarding PMSR, PSUR, PMPF plan/report writing and PMPF strategy.
Process and Templates Development
Proven procedure and document templates are available for all aspects of post-market surveillance and post-market performance follow up including:
- Post-Market Surveillance Procedure
- Post-Market Surveillance Plan
- Post-Market Surveillance Report
- Periodic Safety Update Report
- Post-Market Performance Follow-Up Plan
- Post-Market Performance Follow-Up Report
Gap Assessment
AKRA TEAM offers comprehensive gap assessments of post-market surveillance and post-market performance follow documentation to highlight areas of risk or improvement prior to submission. AKRA TEAM will rank risks from high to low while offering mitigations to close any identified gaps.
Implementation
AKRA TEAM has an experienced team of medical writers, clinicians and regulatory experts available to post-market surveillance and post-market clinical follow documentation related documentation for all device categories and risk-classes. AKRA TEAM can help develop PMPF activities to collect relevant data required for ongoing compliance or to address specific gaps in evidence. We offer custom tailored solutions or comprehensive solutions to addresses the needs of any manufacturer.
Continuous update of documentation
AKRA TEAM additionally offers solutions for continuous documentation updates. AKRA TEAM will schedule and revise documentation (e.g., PMSR, PSUR) at defined intervals to ensure regulatory compliance is maintained according to the expectations of EU IVDR.