What are the main changes with ISO 14155:2026

ISO 14155:2026 was finally published in April 2026 with immediate effect which means that any new study that is started should comply with its requirements. For ongoing studies it is usually tolerated to keep going under the previous version based on risk management decisions. What does this mean? In practice, if a standard brings important changes based on risk management to protect patients rights, well-being or protection or contributes significantly to the scientific outcome of the study, the changes should be taken into consideration for implementation. This may result in , no need for changes at all as the company already applied sufficient requirements, or modifications while performing a planned protocol amendment, or modifications in the quality management system or immediate protocol amendments to achieve the objectives of new compliance.

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ICEPS Launches a Global Community for Clinical Evidence Professionals

The official launch webinar of the International Clinical Evidence Professionals Society (ICEPS) brought together professionals from across the medical device, IVD, regulatory, reimbursement, and clinical research sectors to introduce a new global community dedicated to clinical evidence.

ICEPS was created with a clear mission: to connect professionals involved in the generation of clinical evidence, while fostering collaboration, knowledge sharing, and professional development across the healthcare ecosystem.

During the session, members of the Board of Directors presented the vision behind the association and highlighted the importance of creating an international platform where industry professionals, regulators, academics, healthcare providers, and patient representatives can exchange ideas and address common challenges.

Several upcoming initiatives were announced, including:

A major highlight of the launch was the announcement of the first ICEPS Conference, which will take place in Brussels from 4–5 November in a hybrid format, allowing participation from professionals around the world.

Throughout the webinar, one message remained central: ICEPS is a community built by and for its members. The association encourages professionals to contribute ideas, share expertise, participate in discussions, and help shape the future of clinical evidence.

If you are passionate about advancing clinical evidence, expanding your professional network, and contributing to meaningful discussions that impact the future of healthcare innovation, we invite you to become an ICEPS member. Join a growing international community of experts and help us build the platform that our profession needs.

Watch the full webinar recording to learn more about ICEPS, its vision, upcoming activities, and opportunities to get involved.

Welcome to ICEPS

We are pleased to welcome you to the official platform of the ICEPS-MD IVD network — a space created to support collaboration, knowledge exchange, and innovation in the field of in vitro diagnostic medical devices. We invite you to read the next post with details about our upcoming inaugural meeting this Autumn. We look forward to your participation as we shape this new collaborative journey together.

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