CEN-CENELEC Organ-on-Chip Focus Group Creation

The PSIS workshop gathered more than 200 participants from academia, industry, policy makers, regulatory experts, and standardizers. You can find out more about the workshop and the different themes and issues that were discussed over its two-day run in this event report published by the JRC.

In June, it was decided by CEN and CENELEC Technical Board that a CEN-CENELEC Focus Group on Organ on Chip (FG OoC) would be established. The secretariat of FG OoC is held by NEN, the Royal Netherlands Standardization Institute. The Focus Group shall ensure interaction between all relevant European stakeholders interested in potential standardization in the field of OoC, map ongoing activities, define priority needs and opportunities and recommend further action to ensure that standards support the deployment of OoC in industry and help to ensure its regulatory acceptance.

The primary objectives of this Focus Group will be:

• developing an overview for the stakeholder community on suitable standards already publicly available or in preparation
• developing a roadmap for potential standardization issues relevant for OoC
• identifying and considering technical bodies addressing areas related to OoC technologies, such as ISO/TC 276 Biotechnology, ISO/TC 215 Health Informatics, CEN/TC 140 In vitro diagnostic medical devices, CEN/TC 251 Health Informatics;
• advising CEN and CENELEC Technical Boards on strategic issues concerning standardization within the Group's overall remit and, where no suitable standard exists, the FG OoC should recommend best ways to provide them;
• identifying and considering any relevant specific issues linked to European legislation; liaising with innovation/research projects impacting the field of OoC;
• establishing an active dialogue between stakeholders and liaising with the European Organ-on-Chip Society (EUROoCS) to identify potential synergies.

The Focus Group will be holding its kick-off meeting virtually on 2 March 2022.

Researchers and organizations active in Organ-on-Chip can express their interest in contributing to this Focus Group by contacting their National Standardization Bodies (NSBs-CEN) or National Committees (NCs-CENELEC), who will organise the contributions at national level to the Focus Group.