Team-NB Position Paper: Orphan In Vitro Diagnostic Medical Devices under the IVDR

As the EU continues to revise its pharmaceutical legislation to better address rare diseases and unmet medical needs, there is growing interest in how orphan in vitro diagnostic (IVD) devices fit into the regulatory landscape. While the IVDR does not currently include specific provisions for these devices, their unique characteristics warrant further reflection.

In response, Team-NB has published a new position paper to:

• Propose criteria for defining orphan IVDs;
• Share notified bodies’ views on conformity assessment and performance evaluation under the IVDR;
• Recommend a balanced and proportionate application of pre-market evidence requirements, to avoid delaying patient access to vital diagnostics.

This paper is particularly relevant for stakeholders involved in the assessment and regulation of IVDs for rare conditions.

DOWNLOAD THE TEAM-NB POSITION PAPER