What is BS EN ISO 14155 - Clinical investigation of medical devices for human subjects about?
BS EN ISO 14155:2026 sets out the international principles of Good Clinical Practice (GCP) for clinical investigations involving medical devices used with human subjects.
It provides a comprehensive framework to ensure that clinical studies are ethically conducted, scientifically robust and generate credible evidence on the safety, performance and effectiveness of medical devices.
The standard protects the rights, safety and wellbeing of participants, while defining clear responsibilities for sponsors, investigators, ethics committees and regulators. It applies to both pre market and, where relevant, post market clinical investigations.
Who is BS EN ISO 14155 - Clinical investigation of medical devices for human subjects for?
Users of BS EN ISO 14155:2026 might include:
- Medical device manufacturers – to ensure investigations meet regulatory expectations and support global market access.
- Sponsors and Contract Research Organizations (CROs) – for designing, managing and monitoring clinical investigations.
- Principal investigators and clinical site teams – to guide ethical conduct, data collection and reporting.
- Ethics committees – to support ethical review, oversight and participant protection.
Regulatory authorities and notified bodies – to assess conformity and evaluate clinical evidence.
- Developers of digital health and Software as a Medical Device (SaMD) – to validate software based medical technologies.
- Other users may include healthcare institutions, conformity assessment bodies, clinical research professionals and quality and regulatory specialists.
What does BS EN ISO 14155 - Clinical investigation of medical devices for human subjects cover?
BS EN ISO 14155:2026 sets out the internationally recognized Good Clinical Practice (GCP) requirements for medical device investigations involving human subjects.
It provides a clear, harmonized framework covering ethical principles, study design, risk management, documentation, monitoring, data integrity and reporting. From defining sponsor and investigator responsibilities to guiding adverse event reporting, statistical methods and quality assurance processes, the standard ensures clinical investigations are safe, scientifically robust and aligned with global regulatory expectations.
It applies to both pre market and relevant post market studies, supporting credible evidence generation for successful regulatory submissions and market access.
Why should you use BS EN ISO 14155 - Clinical investigation of medical devices for human subjects?
Organizations should use BS EN ISO 14155:2026 because it:
- Ensures the rights, safety and wellbeing of clinical investigation participants.
- Provides a globally aligned framework that meets EU MDR and international regulatory expectations.
- Delivers scientifically robust, reliable and credible clinical evidence.
- Reduces operational and regulatory risk through clear, harmonized requirements.
- Supports efficient planning, conduct and monitoring of clinical investigations.
- Streamlines documentation and improves data quality and transparency.
- Strengthens trust with regulators, ethics committees and global markets.
- Enables smoother, faster market access by meeting internationally recognized GCP standards.
- Helps organizations avoid costly errors, inconsistencies and compliance gaps.
- Provides structured guidance valuable across pre market and post market investigations.
What's changed?
BS EN ISO 14155:2026 is the fourth edition of the standard, replacing BS EN ISO 14155:2020+A11:2024, with extensive technical revisions. Key updates include:
- Definitions, consent and ethical clarifications
- Updated definition of clinical performance.
- Clearer rules on eligibility deviations (not permitted without CIP amendment).
- Strengthened informed consent requirements (including legally designated representatives).
- Emphasis on allowing subjects time to discuss participation with others.
- Risk management enhancements
- Clearer distinction between device related risks and those from study specific procedures.
- Requirement to assess residual risks.
- Clarified references to investigational device risk.
- Added content on managing risks related to clinical procedures required by the CIP.
- Study design and monitoring improvements
- Requirements from Annex A moved into clause 6.4 (objectives and design).
- Added requirements for data monitoring committees (DMCs) and justification if no DMC is used.
- New section on clinical events committees.
- Clarified conditions for stopping or suspending investigations.
- Adverse event and reporting updates
- Updated AE categorisation and flowcharts (e.g., F1).
- Clarified reduced reporting obligations in certain cases.
- Revised Annex H and associated processes.
- Methodology and statistical updates
- Requirements for non inferiority margins and handling missing data.
- Inclusion of the estimands framework and its attributes.
- Added calibration requirements for equipment.
- Operational and documentation updates
- Requirement for implant cards.
- Clarification of local representative roles.
- New guidance on training, precautions, and use of in silico tests.
- These changes strengthen clarity, harmonization with regulatory expectations, risk management, scientific robustness, and subject protection.
This document specifies the general requirements intended to:
- protect the rights, safety and well-being of human subjects, users or other persons,
- ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results,
- define the responsibilities of the sponsor and principal investigator, and
- assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
- Other standards or national requirements can also apply to the investigational device(s) under consideration or the clinical investigation(s).
NOTE: For Software as a Medical Device (SaMD), where appropriate, demonstration of the analytical validity (the SaMD’s output is accurate for a given input), the scientific validity (the SaMD’s output is associated to the intended clinical condition/physiological state), and clinical performance (the SaMD’s output yields a clinically meaningful association to the target use) of the SaMD, the requirements of this document apply as far as relevant (see Reference [5]). Justifications for exemptions from this document can consider the uniqueness of indirect contact between subjects and the SaMD.
This document does not apply to in vitro diagnostic medical devices. However, there can be situations, dependent on the device and national or regional requirements, where users of this document can consider whether either specific sections or requirements of this document, or both, can be applicable.