Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) under Medical Device Regulation (EU) 2017/745 (MDR)
What’s required for the most suitable clinical investigation strategy?
General Background
Post-Market Surveillance
Post-market surveillance (PMS) under the European Union Medical Device Regulation (EU MDR) refers to the ongoing process of monitoring the safety and performance of medical devices after they have been placed on the market.
According to EU MDR requirements, 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:
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 83(3) of EU MDR, the gathered data should be used:
Additionally, based on the Article 83(3) of EU MDR, 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 clinical evaluation, and the summary of safety and clinical performance, and to 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.
- To contribute to the PMS of other devices (if applicable).
- To detect and report trends.
Manufacturers must update their risk management system based on the information collected during post-market surveillance activities.
If any safety issues or performance problems are identified during post-market surveillance activities, manufacturers must implement 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 PMS activities should be conducted according to a documented PMS plan per Annex III 1.1 of EU MDR. The extent of PMS activities depends on several factors, such as the existing or new risks associated with the medical device, the chosen data sources or the expected quality of the available information on safety and performance
Depending on the device risk classification, the system also must describe the relevant report output either being the PSUR referred to in Article 86 and the post-market surveillance report referred to in Article 85.
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 Clinical Follow-up
Post-Market Clinical Follow-up (PMCF) is a key component of the EU MDR that requires manufacturers to collect clinical evidence about their medical devices after they have been placed on the market.
PMCF is a continuous process that involves the collection, analysis, and evaluation of clinical data about the 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. PMCF is a continuous process that updates the clinical evaluation and should be addressed in the post-market surveillance plan and conduced according to the PMCF plan per Annex XIV Part B of EU MDR.
The PMCF plan should be based on the specific characteristics of the device and its intended use, and should be designed to address any uncertainties or gaps in the clinical evidence that were identified during the pre-market clinical evaluation.
The key steps involved in PMCF under the EU MDR include:
The key steps involved in PMCF under the EU MDR include:
- Developing a PMCF plan: The PMCF plan should describe the methods and procedures for collecting, analyzing, and evaluating clinical data about the device, as well as the specific objectives of the PMCF study.
- Conducting the PMCF study: The PMCF study involves collecting clinical data from a range of sources, including post-market surveillance data, clinical investigations, and literature reviews.
- Evaluating the PMCF data: The PMCF data should be analyzed and evaluated to identify any potential issues or risks associated with the device and to verify its safety and performance.
- Updating the clinical evaluation report: The PMCF data should be used to update the clinical evaluation report for the device, which is used to demonstrate compliance with the EU MDR requirements.
PMCF is a critical component of the EU MDR that helps to ensure the ongoing safety and effectiveness of medical devices in real-world conditions. It is an important aspect of EU MDR compliance and manufacturers must have a robust PMCF 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
Key changes that require the manufacturer´s immediate attention:
Our Services
Training
AKRA TEAM provides training regarding general Post-Market Surveillance and/or Post-Market Clinical Follow-up as well as specific topics regarding PMSR, PSUR, PMCF plan/report writing and PMCF strategy.
Process and Templates Development
Proven procedure and document templates are available for all aspects of post-market surveillance and post-market clinical follow up including:
- Post-Market Surveillance Procedure
- Post-Market Surveillance Plan
- Post-Market Surveillance Report
- Periodic Safety Update Report
- Post-Market Clinical Follow-Up Plan
- Post-Market Clinical Follow-Up Report
Gap Assessment
AKRA TEAM offers comprehensive gap assessments of post-market surveillance and post-market clinical 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 PMCF 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 MDR.
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