Everything You Need to Know About the New Medical Device Clinical Investigation Standard
The publication of ISO 14155:2026 introduces significant changes for sponsors, medical device manufacturers, CROs, clinical investigators, quality professionals, and regulatory teams involved in medical device clinical investigations.
This FAQ answers the most common questions about ISO 14155:2026 and explains the practical steps organisations should take to maintain compliance. Drawing on years of hands-on experience supporting medical device companies, CROs, and clinical research teams, as well as extensive experience delivering GCP and regulatory training, our team provides practical insights that go beyond the requirements of the standard and focus on real-world implementation.
What is ISO 14155:2026?
ISO 14155:2026 is the latest version of the international standard that defines Good Clinical Practice (GCP) for clinical investigations involving medical devices.
The standard provides requirements for:
- Clinical investigation planning
- Study design and conduct
- Participant protection
- Informed consent
- Data integrity
- Safety reporting
- Monitoring and oversight
- Clinical investigation documentation
ISO 14155 is widely recognised by regulators and notified bodies as the benchmark for conducting ethical and scientifically sound medical device clinical investigations.
What changed in ISO 14155:2026?
ISO 14155:2026 introduces important updates to the standard, including:
- Enhanced risk management requirements
- New expectations for Clinical Events Committees (CECs)
- Stronger governance for Data Monitoring Committees (DMCs)
- Increased focus on study design and statistical planning
- Expanded participant protection measures
- Updated informed consent expectations
- More proportionate adverse event reporting requirements
- Greater emphasis on data quality and oversight
The changes are intended to improve participant safety while ensuring reliable clinical evidence is generated throughout the investigation lifecycle.
Has ISO 14155:2020 been replaced?
Yes. ISO 14155:2026 replaces ISO 14155:2020 and represents the current version of the standard.
Organisations should review and update any:
- SOPs
- Work instructions
- Clinical investigation plans
- Risk management procedures
- Training materials
- Quality management system documents
that currently reference ISO 14155:2020.
Is there a transition period for ISO 14155:2026?
At present, there is no formally defined transition period. This means organisations should begin assessing the impact of the new requirements immediately and determine whether updates are required for:
- Ongoing studies
- Planned investigations
- Internal procedures
- Staff training programmes
The sooner organisations understand the changes, the easier implementation will be.
Who needs training on ISO 14155:2026?
Training is important for anyone involved in medical device clinical investigations, including:
- Clinical Affairs Managers
- Clinical Project Managers
- Clinical Research Associates (CRAs)
- Regulatory Affairs Professionals
- Quality Assurance Personnel
- Medical Device Manufacturers
- CRO Teams
- Clinical Investigators
- Study Coordinators
- Clinical Safety Professionals
Even experienced teams familiar with ISO 14155:2020 should review, learn and apply the updates, as several requirements have been expanded or clarified.
Why is ISO 14155 important?
ISO 14155 helps organisations demonstrate that their clinical investigations are conducted according to recognised Good Clinical Practice principles.
Compliance supports:
- Participant safety
- Ethical study conduct
- Reliable clinical evidence
- Regulatory submissions
- Clinical evaluation activities
- Inspection readiness
Failure to apply the standard appropriately can result in inspection findings, quality concerns, and delays to regulatory programmes.
What are the new risk management requirements in ISO 14155:2026?
The 2026 update places much greater emphasis on continuous risk management throughout the clinical investigation lifecycle.
Organisations should now:
- Identify risks systematically
- Assess risks associated with the investigational device
- Evaluate non-routine clinical procedures
- Document risk management decisions
- Continuously review risks during study conduct
Risk management is no longer a one-time exercise completed at study start-up. It must be integrated into the entire investigation process.
What is a Clinical Events Committee (CEC)?
A Clinical Events Committee (CEC) is an independent group of clinical experts responsible for reviewing and classifying clinical events during a study.
ISO 14155:2026 provides clearer expectations around:
- Committee responsibilities
- Independence
- Governance
- Conflict-of-interest management
- Event adjudication processes
Clinical Events Committees can improve consistency across multi-centre clinical investigations and strengthen confidence in study data.
What is a Data Monitoring Committee (DMC)?
A Data Monitoring Committee (DMC) is an independent body that reviews participant safety and study performance during a clinical investigation.
Under ISO 14155:2026:
- Sponsors should define stopping criteria in advance
- Monitoring responsibilities should be documented
- Committee governance must be clearly established
If a DMC is not used, sponsors should document the rationale behind that decision.
How does ISO 14155:2026 affect informed consent?
The revised standard strengthens expectations around informed consent and participant protection.
Organisations should review:
- Consent forms
- Participant information sheets
- Data privacy arrangements
- Withdrawal processes
- Protections for vulnerable populations
The focus is on ensuring participants are fully informed and their rights are protected throughout the investigation.
Does ISO 14155:2026 affect ongoing clinical investigations?
Potentially, yes. Organisations should conduct a gap assessment to determine whether:
- Existing procedures remain appropriate
- Risk management processes need updating
- Oversight structures need modification
- Documentation should be revised
Where changes are not implemented, the rationale should be fully documented.
How does ISO 14155:2026 relate to the EU MDR?
ISO 14155 remains an important standard for generating clinical evidence under the EU Medical Device Regulation (EU MDR).
The standard supports:
- Clinical investigations
- Clinical evaluation activities
- Data collection processes
- Safety monitoring
- Clinical evidence generation
Medical device manufacturers operating under EU MDR should understand how ISO 14155:2026 impacts their clinical and quality processes.
What should organisations do first?
A practical action plan includes:
- Perform a Gap Assessment; Review current processes against ISO 14155:2026 requirements.
- Update Quality System Documentation; Revise SOPs, templates, work instructions, and study documentation.
- Assess Active and Planned Studies; Determine whether updates are needed to existing investigations.
- Train Relevant Personnel; Ensure clinical, quality, and regulatory teams understand the new requirements.
- Maintain Evidence of Compliance; Document all assessments, decisions, and implementation activities.
Is online ISO 14155:2026 training acceptable?
Yes. Online training provides a practical and efficient way to ensure teams understand:
- New ISO 14155 requirements
- Changes from the 2020 edition
- Good Clinical Practice expectations
- Risk management obligations
- Governance responsibilities
The most effective courses focus not only on the requirements themselves but also on how they can be applied in real clinical investigations.
What are the benefits of completing ISO 14155:2026 training?
Training helps organisations:
- Understand the new standard quickly
- Reduce compliance risks
- Improve inspection readiness
- Update quality systems more effectively
- Strengthen participant protection
- Improve data quality and study oversight
Most importantly, training helps teams move beyond theoretical compliance and understand how the requirements should be applied in practice.
Where can I learn about ISO 14155:2026?
Integrity Clinical Compliance offers a dedicated ISO 14155:2026 Online Training Course designed for clinical, regulatory, and quality professionals working in medical devices.
The course covers:
- Key updates in ISO 14155:2026
- Risk management requirements
- Clinical Events Committees
- Data Monitoring Committees
- Informed consent and subject protection
- Clinical investigation oversight
- Practical implementation strategies
Whether you are updating an existing quality system or preparing for future clinical investigations, the course provides a practical introduction to the latest Good Clinical Practice requirements for medical devices.
The full ISO 14155:2026 standard can be purchased directly from the ISO. Our training course has been developed to help clinical, regulatory and quality professionals understand the best ways to apply the requirements of the standard in practice.
