SIST EN ISO 14155:2026

Overview

SIST EN ISO 14155:2026 specifies good clinical practice (GCP) for conducting, documenting, and reporting clinical investigations involving medical devices on human subjects. Developed by the Slovenian Institute for Standardization (SIST) as an adoption of ISO 14155:2026, this standard ensures clinical investigations are scientifically valid, ethically conducted, and deliver reliable data on the safety and performance of medical devices. The scope includes both pre-market and post-market clinical investigations, with principles applicable as relevant to the nature of the study. The standard does not apply to in vitro diagnostic medical devices, but certain sections may be considered if national or regional requirements warrant it.

Key Topics

• Ethical Considerations and Patient Protection

  • Ensures the rights, safety, and well-being of human subjects and users.
  • Emphasizes the need for informed consent and the involvement of ethics committees.

• Scientific and Regulatory Credibility

  • Establishes requirements to ensure scientific integrity and credibility of results.
  • Aligns closely with international and European regulations, notably Regulation (EU) 2017/745.

• Roles and Responsibilities

  • Defines clear responsibilities for sponsors, principal investigators, ethics committees, and regulatory authorities.
  • Includes provisions regarding legal representation for sponsors not established within the EU.

• Planning and Conduct of Clinical Investigations

  • Provides structured guidance on designing investigation protocols, risk management, and site selection.
  • Addresses monitoring, data management, reporting, and documentation to ensure traceability and confidentiality.

• Risk Management

  • Stresses the application of risk management processes (referencing EN ISO 14971) throughout the clinical investigation lifecycle.

• Specific Provisions for Software as a Medical Device (SaMD)

  • Applies key requirements for analytical validity, scientific validity, and clinical performance as relevant to clinical investigations involving SaMD.

Applications

• Medical Device Manufacturers
  Used for the clinical evaluation and conformity assessment of medical devices prior to market authorization or for post-market surveillance.

• Clinical Research Organizations
  Adopts best practices for designing, conducting, and reporting device-related clinical investigations in compliance with international standards.

• Regulatory Authorities and Ethics Committees
  Supports consistent assessment and oversight of device clinical investigations, ensuring alignment with EU and international regulatory expectations.

• Healthcare Providers
  Ensures participation in clinical investigations upholds the highest standards of patient safety and data validity.

• Software Developers (SaMD)
  Provides a reference for demonstrating and documenting the clinical performance and validity of medical device software during human subject investigations.

Related Standards

• EN ISO 14971:2019 - Medical devices - Application of risk management to medical devices
• Regulation (EU) 2017/745 - Medical Devices Regulation (MDR), Annex XV (Clinical Investigations)
• Declaration of Helsinki - Guidance on ethical principles for medical research involving human subjects
• SIST EN ISO 14155:2020 (superseded) - Previous edition replaced by SIST EN ISO 14155:2026

Practical Value

Compliance with SIST EN ISO 14155:2026 demonstrates a commitment to ethical conduct, scientific rigor, and regulatory alignment in clinical investigations for medical devices. Adhering to this standard helps:

• Protect participant safety and rights
• Enhance the credibility and reproducibility of clinical data
• Facilitate smoother regulatory approvals within the EU and internationally
• Foster trust among patients, users, sponsors, and regulatory bodies

For organizations seeking CE marking and market access within Europe, adopting this standard provides recognized pathways for meeting regulatory requirements and ensures that clinical investigations are designed and conducted to the highest global standards.