ISO 14155:2026 Update: What Changed for Medical Device Clinical Investigations
Understand the key changes from ISO 14155:2020 and how the revised Good Clinical Practice requirements affect the planning, conduct, oversight, and reporting of medical device clinical investigations.
Training Overview
Published in March 2026, the fourth edition of ISO 14155 replaces ISO 14155:2020 and introduces a technical revision of the Good Clinical Practice standard for medical device clinical investigations. This two-day virtual training examines the most important updates and their practical implications for teams responsible for planning, conducting, monitoring, and reporting clinical investigations. Participants will review changes related to risk management and residual risks, informed consent, clinical investigation planning and oversight, adverse event reporting, data monitoring and clinical events committees, statistical considerations, subject follow-up, and other areas strengthened or clarified in the 2026 edition. The course will also place these updates within the broader MDR, ICH-GCP, and GDPR context.
- Dates: December 1, 2026
- Time: 9:00–10:00 AM ET / 15:00–16:00 CEST
- Format: Virtual
- Duration: 60 minutes
- Instructor: Sofia Spjuth, VP Clinical Affairs, Europe
- Price: Free
Sofia Spjuth
Vice President, Clinical Affairs, Europe
Sofia brings over 13 years of experience in MedTech, with responsibility for clinical operations in Europe. She is nominated as a Swedish expert in ISO/TC 194 WG 4 and contributes to committees across medical devices, implants, biocompatibility, and biotechnology.
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Training Objectives
Participants will learn how to:
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Identify key changes introduced in ISO 14155:2026 compared with ISO 14155:2020.
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Understand how the revised requirements affect the planning, conduct, oversight, and reporting of medical device clinical investigations.
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Recognize strengthened expectations related to risk management, residual risks, informed consent, safety reporting, and investigation oversight.
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Understand updates affecting clinical investigation design, data monitoring, clinical events committees, missing data, estimands, and subject follow-up.
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Consider how the 2026 revision should be reflected in clinical investigation processes, documentation, and quality systems.
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Training Content
By attending this training, you will gain practical insight into ISO 14155:2026 and key areas of change, including:
- Overview of ISO 14155:2026 and the regulatory context
- Key changes from ISO 14155:2020 and implications for clinical investigation teams
- Updated Good Clinical Practice principles and relationship to ICH-GCP
- Informed consent and eligibility criteria clarifications
- Risk management, including device-related risks, procedure-related risks, and residual risk assessment
- Clinical investigation planning and design
- Clinical performance, safety and performance claims, and Clinical Development Plan considerations
- Data monitoring committees and the new clinical events committee requirements
- Adverse event reporting, investigation suspension, and premature termination
- Statistical considerations, including missing data, non-inferiority margins, and estimands
- Subject follow-up, continued care, and implant card considerations
- Roles and responsibilities of clinical investigation stakeholders
- Sponsor, Principal Investigator, Ethics Committee, and Competent Authorities
- Essential documents, submission and authorization considerations
- Monitoring activities and clinical quality management
- Handling of the investigational medical device and study close-out
- Practical considerations for implementing the revised standard within existing clinical investigation processes
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Training Format
- Live virtual webinar
- Expert presentations
- Engaging case studies
- Live audience Q&A
- Recording available to registrants
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Prerequisite
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A general understanding of the EU MDR and clinical evaluation requirements is recommended.
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Target Audience
- Clinical Evaluation Specialists
- Regulatory Affairs Professionals
- Quality Assurance Leaders
- Medical Device Manufacturers
- MDR Project Managers
- Clinical Affairs Teams
- Technical Documentation Authors
- Regulatory Consultants
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Price
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Free
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