Medical devices containing tissues and cells 

When gene or cell therapies are incorporated as an integral part of a medical device (MD), they should be regulated as medical devices.

This is relevant for:

non-viable tissues and cells of animal origin: the MD is regulated by Regulation (EU) 722/2012.
non-viable tissues and cells of human origin, the action of which is ancillary to that of the medical device: the MD is regulated by Regulation (EU) 2017/745.

Please see also the EuroGCT poster presented at the ESGCT 2025 in Sevilla: "What Regulatory pathways for health technologies using both medical devices and tissues and cells in the European Union?"

Acknowledgements

Published: 08/12/2024

Authors:

Aurélie Mahalatchimy, EuroGCT WP4 Convenor, UMR 7318 DICE CERIC, Aix-Marseille University, CNRS, Aix-en-Provence, France

Valentin Roby, EuroGCT information officer on Ethical, Legal and Societal Issues

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