Guiding Principles of ISO 14155 for PMCF Surveys for Medical Devices

Introduction:

Post-Market Clinical Follow-up (PMCF) surveys have become a vital tool for ongoing assessment and validation of device performance and safety. The integration of ISO 14155 guidelines into PMCF activities offers regulatory professionals a robust framework to ensure thorough and compliant post-market surveillance. This blog aims to shed light on how ISO 14155 influences PMCF surveys and how professionals can harness its guidelines to optimize post-market activities.

ISO 14155: A Vital Tool for PMCF Surveys

ISO 14155, titled ‘Clinical investigation of medical devices for human subjects — Good clinical practice,’ while primarily known for guiding pre-market clinical trials, also provides invaluable insights for conducting PMCF surveys. These surveys are essential components of a medical device’s lifecycle, offering real-world data critical for assessing long-term safety and effectiveness.

Application of ISO 14155 in PMCF

  • 1. Ethical Considerations: Even in post-market settings, ISO 14155’s emphasis on ethical conduct remains paramount. Ensuring ethical considerations in PMCF surveys aligns with international guidelines and maintains the integrity of the surveillance process.
  • 2. Data Quality and Consistency: The standard’s guidelines on data management, integrity, and reporting are crucial for PMCF surveys. They ensure the collection of high-quality, reliable data, vital for ongoing assessment of the medical device.
  • 3. Risk Management: Ongoing risk assessment, as outlined in ISO 14155, is critical in PMCF surveys. It ensures that any emerging risks are identified and mitigated promptly.
  • 4. Informed Consent: The requirement for informed consent, a cornerstone of ISO 14155, extends to PMCF surveys, ensuring that participants are fully aware of the nature and purpose of the post-market surveillance.

The Role of Regulatory Professionals in PMCF Surveys

Regulatory professionals play a key role in integrating ISO 14155 into PMCF activities. Their expertise ensures that post-market surveillance not only complies with regulatory requirements but also adheres to the highest standards of ethical conduct and data integrity.

Overcoming Challenges in PMCF

Implementing ISO 14155 in PMCF surveys can present challenges, particularly in aligning post-market activities with the rigor of a standard primarily designed for pre-market clinical trials. Professionals must navigate these challenges by adapting the standard’s principles to the specific context of PMCF surveys.

Best Practices for PMCF Surveys under ISO 14155

  1. 1. Adapting ISO 14155 Principles: Tailor the guidelines of ISO 14155 to fit the unique requirements of PMCF surveys, focusing on ethical conduct, data integrity, and risk management.
  2. 2. Stakeholder Engagement: Collaborate with healthcare professionals, patients, and other stakeholders to gather comprehensive post-market data.
  3. 3. Continuous Training: Ensure that teams involved in PMCF activities are regularly trained on the latest ISO 14155 guidelines and their application in post-market settings.
  4. 4. Robust Documentation: Maintain detailed documentation of PMCF activities, as required by ISO 14155, to demonstrate compliance and support ongoing regulatory submissions.

Conclusion: Elevating PMCF Surveys Through ISO 14155 and Cetas Healthcare

The integration of ISO 14155 into Post-Market Clinical Follow-up (PMCF) surveys marks a significant stride in medical device regulation and safety. For regulatory professionals, this is not just about compliance but about elevating post-market surveillance to a higher standard. As the only global market research agency that is ISO 14155-compliant, Cetas Healthcare is setting a new industry benchmark in the conduct of PMCF surveys. Our rigorous adherence to these comprehensive guidelines ensures that we are at the forefront of ensuring that medical devices continue to meet the highest possible standards of safety and effectiveness in real-world scenarios. Know more about our Clinical and Regulatory Services(redirect to clinical page)

Prem Pandey

Prem Pandey

Head of EU MDR Compliance

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