Post-Market Surveillance: A Guide for Medical Device Developers
In the world of medical device development, Post-Market Surveillance (PMS) plays a crucial role in ensuring the safety and effectiveness of these devices. It is essential for medical device developers to have a comprehensive understanding of Post-Market Surveillance, as it is closely linked to the process of clinical evaluation.
Before diving into the intricacies of Post-Market Surveillance, it is important to grasp the concept of clinical evaluation. Clinical evaluation serves as the foundation for Post-Market Surveillance, as it involves the assessment of a medical device's performance and safety in real-world clinical settings.
By understanding the significance and activities of clinical evaluation, medical device developers can better appreciate the importance and steps of Post-Market Surveillance.
This guide will provide you with valuable insights and practical tips to navigate the realm of Post-Market Surveillance, ensuring that your medical device meets the highest standards of safety and efficacy. So let's delve into the world of Post-Market Surveillance and unlock its potential for your medical device development journey.
Clinical Evaluation as lifecyle process
The goal of clinical evaluation is to establish the clinical evidence supporting the device's safety and performance in the market. This is key for the decision that the product may be used within the scope of a regulates health markt, and therefore the first report on clinical evaluation must be presented with the application for market access.
Clinical Evaluation is a process that continues throughout the product lifecycle and is proceeded with Post Market Surveillance activities after the product was placed on the market. Data collected during Post-Market Surveillance feeds back into the clinical evaluation process. So activities for clinical evaluation will also have to be followed for Post-Market Surveillance.
Clinical Evaluation includes the following activities.
Literature Review
The objective is to gather existing information on the device's safety and performance from published scientific literature, clinical studies, and other relevant sources. Mostly, devices of the same intended use and the same or similar technologies are used for identifying relevant literature sources. Gaps between the existing knowledge and the device evaluated are identified for further data gathering activities and research goals.
Device Description
The objective is to have a comprehensive description of the medical device to allow identification of similar devices. The device description must include its intended use, design, materials, and specifications. While some parts of the device description is only available after product design and production, intended use and the technological approach in early design phases can be used to derive design requirements from state of the art information regarding the intended use and technology, or from comparable devices in the market.
Also, part of the device description for the clinical evaluation should be the identification of the product in the market - labelling and identification standards like UDI for EUDAMED information in he EU, or other public or company wide device repositories.
Risk Management
The goal of risk assessment is to Identify, assess, and mitigate potential risks associated with the device's use. Activities include a risk analysis, including hazard identification, the implementation of risk control measures and evaluation of their effectiveness. The risk management process must be thouroughly documented and updated whenever feedback from tests, validations and users occur, or product or processes are changed
Clinical Data Generation
Whenever clinical data can not be obtained from comparable devices in the market, new clinical data must be generated through clinical investigations, studies, or other appropriate means. Clinical trials or studies must be planned and conducted as needed, and data collected on the device's safety, performance, and clinical benefit.
Appraisal of Clinical Data
To critically assess the quality and relevance of the collected clinical data, the scientific validity and reliability of the data must be evaluated, and the appropriateness of study designs and methodologies must be considered. The strength of the evidence supporting the device's safety and performance must be determined and discussed in the clinical evaluation report.
Summarize outcome in the Clinical Evaluation Report (CER)
The CER primarily focuses on demonstrating regulatory compliance through clinical evidence and risk assessments supporting the device. The CER covers the entire lifecycle of the device, including the design and development phases. The CER includes in-depth clinical data, risk assessments, and the analysis of the benefit-risk ratio. The main outcome in the CER are the conclusions drawn from the clinical evaluation.
Define ongoing evaluation in the Post-Market Surveillance (PMS) Plan
The Post-Market Surveillance (PMS) plan is base for ongoing monitoring of medical devices once they are on the market.
It includes information about the device, regulatory context, roles and responsibilities, and methods for data collection and analysis. The plan outlines triggers for specific actions, communication strategies, and mechanisms for continuous improvement, emphasizing changes to product design and realisation, and linking to documentation, training, and audit processes.
A well-structured PMS plan ensures compliance with regulatory requirements, facilitates efficient data monitoring, and contributes to the overall safety and performance of medical devices throughout their lifecycle. The PMS plan should be a dynamic document that evolves as the device matures and as new information becomes available.
Post-Market Surveillance as process after market access
Post-market Surveillance kicks in after the device has been placed on the market. It involves continuous monitoring of the device's real-world performance, including the collection of data from sources like complaints, adverse events, and literature reviews. Post-Market Surveillance helps identify any issues that may not have been evident during pre-market clinical evaluation.
In the context of the post-market phase of a medical device, it's crucial to consider Post-Market Clinical Follow-up (PMCF) activities. Clinical Evaluation Reports (CER) and Summary of Safety and Clinical Performance (SSCP) are integral components of Post market Surveillance. PMCF activities serve as valuable inputs in PMS for refining and updating these documents. It's important to recognize that a seamless flow exists between PMCF activities and the enhancement of CER or SSCP, contributing to the Post-Market Surveillance practices.
PMS activities must be based on the product, its risks and available clinical evidence and clinical evaluation. To effectively plan the activities after the market access of a product, these activities need to be planned and prepared to meet the requirements to effectively retrieve feedback from the market, and respond to potential issues. That makes it necessary to get also real-word information about the environment and users of the device in the pre-market phase. Plans and readiness for post-market activities for product feedback monitoring and effective response must be provided for the compliance evaluation by Notified Bodies. They will at least expect a draft for such reports before initial certifications and will then check during recurring audits if manufacturers are complying with the set limits.
Post-Market Surveillance Activities
Literature Reviews
Make sure to monitor relevant literature sources for new evidence and reported incidents within the intended use and the technology of the medical device, and add them to the ongoing product or process risk assessment and requirements management.
Adverse Event Reporting
This requires a systematic collection and reporting of adverse events of the medical device in the market. Methods and tools must be in place to allow authorities, users and patients to effectively give feedback on adverse events, and to respond to these incidents promptly. This includes the need for manufacturers to promptly report to regulatory authorities on adverse events of their devices. Standardized communication paths and product repositories like EUDAMED make it easier for manufacturers to support the need for transparency and traceability regarding adverse events in the healthcare markets. Information in these repositories from similar devices can be used as input for post market surveillance.
Complaint Handling
Complaint handling for medical devices is a crucial aspect of Post-Market Surveillance, ensuring the continuous monitoring and improvement of device safety and performance. The complaint handling process involves systematic collection, analysis, and response to these complaints which requires well layed-out processes in the quality management system of the manufacturer.
Key components of Complaint Handling are:
Reporting:
Complaints can arise from various sources, including users, healthcare providers, or internal monitoring systems. Timely and accurate reporting of complaints is essential for initiating the complaint handling process. Manufacturers need tools and processes for feedback collection and response.
Recording and Documentation:
Each complaint should be meticulously documented, capturing details such as the nature of the issue, date of occurrence, and the individuals involved. Proper documentation ensures a comprehensive understanding of the complaint for analysis and response.
Investigation:
Thorough investigation aims to identify the root cause of the issue, whether it's related to device design, manufacturing, labeling, or user error. A systematic approach helps in determining the severity and potential impact on patient safety.
Risk Assessment:
A risk assessment is conducted to evaluate the potential risks associated with the reported issue. This step helps prioritize actions based on the level of risk posed by the complaint.
Corrective and Preventive Actions (CAPA):
Corrective actions address the immediate concern, resolving the reported issue. Preventive actions are implemented to mitigate the likelihood of similar issues in the future, improving overall device quality.
Communication:
Effective communication is maintained throughout the process, both internally and externally. Stakeholders, including regulatory authorities, may need to be informed of significant complaints and their resolutions.
Documentation of Resolution:
Every step of the complaint handling process, including the actions taken, is documented. Proper documentation ensures transparency and compliance with regulatory requirements.
Continuous Improvement:
The information gathered from complaint handling feeds into the overall Post-Market Surveillance and clinical evaluation processes. Continuous improvement strategies are implemented to enhance device safety and performance based on the insights gained from complaint analysis.
Obviously, for effective Complaint Handling, traceability from reported effects to product specifications and risks is essential, as well as traceability from a reported incident to the measures that were taken to report and to solve the problem - may that be process or product changes, and their verification and validation for release to the market. Documentation that automatically includes changes in processes and product design also would support an effective complaint handling process.
Trend Analysis
Evaluating the monitoring activities and complaint handling requires implementing of data analysis tools to identify trends in reported events, and to retrieve proactive measures to address emerging issues.
Post-Market Clinical Follow-Up (PMCF)
The role of PMCF is to ensure th ongoing clinical evaluation as continuous clinical evidence collection process. It allows to incorporate real-world data into device monitoring and improvement. In PMCF, data on new or existing side effects, adverse events relating to use of the device and systematic misuse of the device in practice must be collected. Their evaluation, and information from other feedback methods will be used to detect any emergent risks that have not been considered in the device’s Risk Management activities, and harvesting data on the frequency and severity of harms identified in existing Risk Management documentation. To improve clinical evidence, information about the safety and performance of the device in normal use shall also be collected. A well-designed PMCF survey or even a PMCF system, set up by an experienced PMCF design service, can support this process for manufacturers.
Reports for documentation of PMS results
Post market Surveillance Report (PMSR)
Tailored for Class I medical devices, the PMSR is the most straightforward report. It doesn't follow a strict reporting schedule and should be updated as needed. However, like all others, this reports needs to contain the results of Post-Market Surveillance activities and their evaluation and the final validation in regard to the clinical data and product safety and performance.
Periodic Safety Update Reports (PSUR)
The Periodic Safety Update Report (PSUR) is a comprehensive document that provides a systematic assessment of the safety profile of a medical device over time. It includes an analysis of adverse events, product-related risks, and the overall benefit-risk balance. The content typically encompasses updated clinical data, risk management activities, and any emerging safety concerns. As a step up from PMSR, PSUR targets devices above Class I. High-risk devices need an annual update, while medium-risk ones are updated every two years, and on demand according to feedback from PMS activities.
Notified Bodies will at least expect a draft for such reports before initial certifications and will then check during recurring audits if manufacturers are complying with the set limits.
Summary of Safety and Clinical Performance (SSCP)
The SSCP focuses on providing transparent and accessible information about a device's safety and performance to stakeholders, including healthcare professionals and patients. The SSCP focuses on the post-market phase, capturing real-world performance and ongoing surveillance activities. The SSCP provides a concise summary of essential safety and performance information, emphasizing real-world data and Post-Market Surveillance activities. The unique SSCP is mandatory only for implants and Class III devices. The SSCP is publicly accessible via EUDAMED, ensuring transparency right down to the patient level, and on the manufacturer's website,
The SSCP should be ready before you start the certification process.
Best Practices for Post-Market Surveillance
Use of a QMS for process documentation
Have ISO 13485 or FDA 820 as base for the QMS to include regulatory requirements for post-market processes. Make sure the QMS defines steps, roles and responsibilities for activities in PMS, and links templates for PMS plans and reports.
Establish a Robust PMS Plan
Consider the risk-class of the medical device, and refer to risk assessment and clinical evaluation results to derive monitoring targets for pro-active feedback measures. In a SAMD or SiMD, monitoring measures can be supported by software functions.
Include methods and tools for feedback collection, define and document roles and responsibilities for PMS activities in the PMS plan. Define response processes, activities and communication interfaces with other organizations that contribute to product realisation and marketing. Integrate risk management into PMS strategies and make sure a tool eases traces from market feedback to risk management. Trace activities and definitions in the PMS plan to your QM, product realisation and documentation systems.
Collaborate with Stakeholders
Engage with healthcare professionals, patients, and regulatory authorities, build a collaborative ecosystem for effective Post-Market Surveillance.
Rapid Response to Safety concerns
Whenever safety concerns arise - from feedback outside or inside your organization - make sure you have the right processes and tools for effective user information, recalls, product modifications and update of product documentation.
Processes and Systems to support modifications of the product
Digitalised interlinked information and data for management of incidents, risks, product design and other relevant processes is the base for fast response and effective change management. The Quality Management and Documentation System should make sure documentation is updated with correct information after changes were implemented. Make sure to have an overview of change implementation throughout all design and production phases. Traceability of incidents and product modifications must be supported, as well as traceability of product versions and product configuration in relation to market feedback, evaluations and changes of the product and its components. Not at least the processes and documentation tooling should support re-evaluation of product safety and performance after changes reusing existing information, and adoption and updating of existing reports.
Post-Market Surveillance plays an important role in building trust and ensuring patient safety.
Utilizing a digital tool like MatrixRequirements platform with item-based eQMS and eTD allows to trace from relevant regulatory requirements through processes and product information to risk management and verifications/validations, while market feedback and complaints can be documented and linked to the responding measures and changes in processes and product design and documentation.