The Importance of Post-Market Clinical Follow-up for Medical Devices: Compliance and Beyond

Medical Device manufacturers have to follow regulatory frameworks of different countries and regions for access to their markets. The onus is on the manufacturers to ensure continuous monitoring and of the safety and performance of their products. Post market clinical follow up (PMCF) for medical devices is a requirement to comply with regulations in the following countries/regions:

• United States Food and Drug Administration (FDA)
• European Union (European Medical Device Regulation (EU MDR)
• Health Canada (HC)
• Australia Therapeutic Goods Administration (TGA)
• Japan Pharmaceuticals and Medical Devices Agency (PMDA)
• China National Medical Products Administration (NMPA)
• South Korea Ministry of Food and Drug Safety (MFDS)
• Brazil Agência Nacional de Vigilância Sanitária (ANVISA)
• Indian Central Drugs Standard Control Organization (CDSCO)
• Russian Ministry of Health
• Singapore Health Sciences Authority (HSA)
• Taiwan Food and Drug Administration (TFDA)
• Mexico Federal Commission for the Protection against Sanitary Risk (COFEPRIS)
• Argentina National Administration of Drugs, Food and Medical Technology (ANMAT)
• Saudi Arabia Food and Drug Authority (SFDA)

The PMCF Process

The PMCF process is important for medical device manufacturers not just as a regulatory requirement. A robust PMCF strategy demonstrates commitment to safety and product excellence, inspiring confidence in their devices among patients and healthcare professionals. There are significant advantages of proactively collecting post market data:

• Tailored Surveillance Strategies: Implementing targeted PMCF Plans enables proactive risk mitigation.
• Transparent Reporting: Showcasing commitment to safety and regulatory compliance by reporting relevant data from the post market life cycle of the device to the authorities.
• Collaborative Approach: Fostering communication and collaboration among stakeholders to swiftly address any post-market concerns and uphold patient safety.
• User Experience Optimization: Proactively identifying usage-related issues for better patient outcomes.
• Data-driven Innovation: Applying real-world feedback to enhance device features.
• Strengthen Clinical Evidence: Utilizing real-world evidence for better clinical decision-making.
• Enhanced Safety and Performance: Overall improvement in device safety and performance.

It is now abundantly clear that under the EU MDR, PMCF is not an optional requirement. Devices of all classes, including legacy devices, require a PMCF Plan documenting the activities undertaken to ensure continuous safety and performance monitoring. Manufacturers are required to implement PMCF as part of their post-market surveillance (PMS) obligations. Failure to develop and execute a robust PMCF Plan can result in non-compliance and potential regulatory sanctions.

• Understand Regulations: Start by grasping the regulatory requirements pertinent to your device.
• Assess Risk: Conduct a thorough risk assessment to identify potential safety and performance issues, focusing on devices with higher risks.
• Consider Device Characteristics: Tailor your PMCF approach based on your device’s unique features, intended use, risk category, and the level of unknowns.
• Utilize Clinical Data: Leverage existing clinical data from pre-market studies to inform your PMCF activities and address knowledge gaps.
• Seek Stakeholder Input: Engage with stakeholders to gain insights into real-world device use and align PMCF activities with user needs.
• Allocate Resources Wisely: Balance the need for comprehensive surveillance with resource limitations, ensuring practical and sustainable PMCF activities.
• Embrace Continuous Monitoring: Establish mechanisms for ongoing review and refinement of PMCF activities, adapting to emerging data and regulatory changes.

Existing data may influence the selection of PMCF activities and help identify gaps in knowledge that need to be addressed through PMS. Devices with higher risks may warrant more extensive PMCF activities to ensure ongoing monitoring and compliance with regulatory standards. Devices with novel features, implantable components, or unique indications may require tailored PMCF approaches to address specific safety and performance concerns.

Notified Bodies and PMCF

Notified bodies expect PMCF Plans in accordance with the template provided in the MDCG 2020-7 guidance document, documenting strategies for collecting and analyzing real-world post market data on device usage, performance, clinical benefits, and adverse events. These activities could include user surveys, literature reviews, data analysis of clinical data (electronic health records, registries, or clinical trials), complaint handling and adverse events reporting (trend reporting and adverse event database searches), clinical studies/trials addressing specific safety or performance concerns identified by regular PMS activities), and quality management system audits. These strategies ensure that manufacturers fulfil their PMS obligations, identify potential issues early, and establish continued safety and performance of their products.

A user survey can be an effective PMCF activity when conducted using scientifically valid methods, in compliance with regulatory requirements, and with a focus on generating meaningful and actionable data to support ongoing device monitoring and safety. Consider the following when planning a user survey:

• Align Objectives: Ensure survey objectives fulfil the purpose of data gathering.
• Design a Scientific Survey: Use validated methods to gather data on safety, performance, and usability.
• Determine Sample Size: Calculate an appropriate sample size for statistical validity.
• Recruit Participants: Target users representing the device’s intended population.
• Collect and Analyze Data: Gather responses systematically and assess data for statistical and clinical significance.
• Uphold Ethics: Follow ethical guidelines, including informed consent and confidentiality.
• Report Findings: Document survey methodology and share results transparently for regulatory compliance and stakeholder awareness.

Benefits of User Surveys for PMCF

User surveys are cost-effective, as they require fewer resources for design, recruitment, and data collection. Surveys also allow data collection within a short duration, allowing manufacturers to gather user input quickly, compared to the lengthy duration of clinical studies. Additionally, surveys are easier to implement and administer, requiring less logistical coordination and also facilitate easier participant recruitment. They can reach a larger and more diverse user base, offering a broader perspective across different populations.

User surveys offer manufacturers valuable insights into device usage in real-world scenarios, aiding in identifying areas for improvement and enhancing overall usability. Surveys aid in identifying safety concerns and adverse events, enabling manufacturers to implement corrective actions and enhance safety measures. Survey data facilitate timely troubleshooting and refinement of features, and validate proposed design changes, ensuring alignment with user needs. In summary, user surveys are a beneficial tool for manufacturers to gather actionable insights, enhance device design, mitigate risks, and bolster customer satisfaction.

The conclusions from the PMCF data must be documented in the PMCF Evaluation Report, which must also include as assessment of the impact of the PMCF outcomes on other parts of the technical documentation, such as updates to risk management file, clinical evaluation report, instructions for use/user manual, or changes to design documents, or additional verification/validation requirements.

If you need any assistance with PMCFs for EU MDR compliance then reach out to us at info@celegence.com or contact us online for more information.