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ISO 14155:2020 Explained: Navigating the Landscape of Medical Device Clinical Investigations
ISO 14155:2020 Explained: Navigating the Landscape of Medical Device Clinical Investigations
Clinical investigations serve as the bedrock for substantiating the performance and safety of medical devices. Amidst the constantly changing landscape of regulations and standards, ISO 14155 stands out as a crucial framework guiding the conduct of clinical investigations.
With the release of the 2020 edition, it's imperative for medical technology companies to grasp the nuances of this standard to navigate the complexities of clinical research effectively.
What is ISO 14155?
ISO 14155 is an international standard providing guidelines for the design, conduct, recording, and reporting of clinical investigations carried out on medical devices. Developed by the International Organization for Standardization (ISO), this standard aims to ensure the ethical conduct of clinical trials and the generation of reliable clinical data supporting the evaluation of medical device performance and safety. You can learn more about ISO audits here.
What’s New in the 2020 Edition of ISO 14155?
The 2020 edition of ISO 14155 brings several notable updates and revisions, reflecting the evolving landscape of medical device regulations and best practices. Key changes include:
Expanded Scope: The standard now encompasses a broader range of medical devices, including in vitro diagnostic devices (IVDs) and combination products, reflecting the diversity of technologies in the medical device sector.
Enhanced Risk Management Requirements: Emphasizing the importance of risk management throughout the clinical investigation process, the 2020 edition provides clearer guidance on risk assessment, mitigation, and communication strategies.
Incorporation of Electronic Data Capture (EDC): Recognizing the increasing prevalence of electronic data capture systems in clinical research, the standard offers guidance on ensuring the integrity, security, and compliance of electronic data in accordance with regulatory requirements.
Updated Regulatory References: Aligning with current regulatory expectations, ISO 14155:2020 references updated regulatory requirements, including the European Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).
Implementing ISO 14155 for Compliance with Medical Device Standards
Achieving compliance with ISO 14155 is not merely a regulatory obligation but a strategic imperative for medical technology companies. By adhering to the principles outlined in this standard, organizations can:
Enhance Patient Safety: Rigorous adherence to ISO 14155 ensures that clinical investigations are conducted ethically and with the utmost regard for patient safety, thereby minimizing potential risks associated with medical device use.
Facilitate Market Access: Compliance with ISO 14155 enhances the credibility of clinical data, streamlining the regulatory approval process and expediting market access for medical devices, ultimately driving revenue growth and market competitiveness. Learn more about Clinical Evaluation Reporting here.
Mitigate Legal and Reputational Risks: Non-compliance with regulatory standards can expose companies to legal liabilities and reputational damage. Implementing ISO 14155 mitigates these risks by demonstrating a commitment to quality, compliance, and ethical conduct. It's important to also understand how to navigate EU MDR certification to ensure a smooth compliance roadmap.
Conducting Clinical Investigations in Line with ISO 14155:2020
Effective implementation of ISO 14155 requires a systematic approach encompassing various stages of the clinical investigation process:
Protocol Development: Develop a comprehensive study protocol outlining the objectives, methodology, participant eligibility criteria, and data collection procedures in accordance with ISO 14155 requirements.
Site Selection and Monitoring: Select investigational sites with the requisite expertise and infrastructure to conduct clinical investigations effectively. Implement robust monitoring procedures to ensure compliance with the protocol and regulatory requirements.
Informed Consent Process: Obtain informed consent from study participants in accordance with ethical principles and regulatory guidelines, ensuring that participants understand the nature of the study, potential risks, and benefits.
Data Management and Analysis: Establish robust data management systems to capture, analyze, and report clinical data accurately and reliably. Adhere to ISO 14155 guidelines for data collection, handling, and documentation to ensure data integrity and traceability.
Adverse Event Reporting: Implement proactive mechanisms for monitoring and reporting adverse events occurring during the course of the clinical investigation, in compliance with regulatory requirements and ethical standards. You can learn more about CAPAs here.
Risk Management in Clinical Investigations
Risk management is a cornerstone of ISO 14155, emphasizing the proactive identification, assessment, and mitigation of risks associated with clinical investigations. Key principles of risk management in clinical investigations include:
Risk Identification: Identify potential risks associated with the medical device, study protocol, participant population, and investigational sites.
Risk Assessment: Evaluate the severity, probability, and detectability of identified risks to prioritize risk mitigation efforts.
Risk Mitigation: Implement risk mitigation measures to minimize the likelihood and impact of identified risks, incorporating strategies such as protocol modifications, participant monitoring, and training.
Risk Communication: Maintain open and transparent communication regarding identified risks, ensuring that stakeholders are informed and engaged in risk management activities throughout the clinical investigation process.
Ensuring Electronic Data Capture Compliance with ISO 14155:2020
As many businesses undergo digital transformation, electronic data capture (EDC) systems play a pivotal role in streamlining data collection, management, and analysis in clinical investigations. To ensure compliance with ISO 14155:2020, organizations should:
Select Validated EDC Systems: Choose EDC systems that have been validated for compliance with regulatory requirements and industry standards, ensuring data integrity, security, and traceability.
Implement Data Security Measures: Implement robust data security measures to safeguard electronic data against unauthorized access, manipulation, or loss, in accordance with ISO 14155 requirements and applicable data protection regulations.
Conduct Regular Audits and Inspections: Conduct regular audits and inspections of EDC systems to ensure ongoing compliance with ISO 14155 standards and regulatory requirements, addressing any identified non-conformities promptly and effectively.
Post-market surveillance with data capture compliance under ISO 14155:2020
Integrating post-market surveillance with data capture compliance under ISO 14155:2020 is essential for ensuring comprehensive medical device safety, effectiveness, and regulatory compliance throughout the device lifecycle.
Post-market surveillance enables real-world performance monitoring, early detection of adverse events, and compliance with regulatory requirements by continuously monitoring device performance, identifying safety concerns, and implementing corrective actions.
Furthermore, it helps to ensure continuous improvement and innovation by providing valuable insights for product enhancement and development based on real-world data. By seamlessly integrating post-market surveillance with data capture compliance, organizations can enhance patient safety, maintain regulatory compliance, and drive continuous improvement in the medical technology sector.
The ISO 14155 framework
ISO 14155:2020 serves as a guiding framework for the ethical conduct and rigorous management of clinical investigations in the Medical Devices field. By embracing the principles outlined in this standard and adopting a systematic approach to compliance with a QMS and ALM, medical device companies can navigate the complexities of clinical research with confidence, ensuring the generation of robust clinical data supporting the safety and efficacy of their products.