In Team-NB Position Paper on Orphan IVDs (July 2025) Team-NB is urging the Commission to create tailored pathways under the IVDR for orphan IVDs—offering proposals for adaptive conformity assessment, targeted expert advice, and enhanced incentives that aim to strike the balance between safety and innovation.
In its latest position paper published in July 2025, Team-NB—the European Association of Notified Bodies—calls for the development of a dedicated and proportionate regulatory framework for in vitro diagnostic medical devices (IVDs) intended for very small patient populations, commonly referred to as orphan IVDs. The document, addressed primarily to the European Commission, presents specific legislative and operational proposals aimed at removing barriers that hinder access to highly needed but niche diagnostic solutions.
Orphan IVDs: small group of users, high risk of unavailability
Team-NB notes that the current provisions of the IVDR do not include tailored flexibilities for IVDs intended for diagnosing rare diseases, despite similar mechanisms already being in place for medicinal products (i.e., orphan drugs). For diagnostic devices with an extremely limited target population, the IVDR requirements—particularly in terms of the volume of clinical evidence and the costs of conformity assessment—may be disproportionately burdensome.
Team-NB warns that, without the introduction of appropriate regulatory mechanisms, many innovative IVDs may never reach the European market, even when their potential clinical value for diagnosing rare conditions is significant.
Three key pillars of Team-NB’s proposed approach
The position paper outlines three core pillars on which a future support system for orphan IVDs should be based:
- Flexible conformity assessment – A proposal to introduce simplified conformity assessment pathways, relying on a limited but scientifically justified set of clinical data. Notified Bodies should take into account the challenges associated with low-prevalence populations and data collection constraints.
- Expert advisory support – The establishment of dedicated expert panels (modeled after EMA advisory structures) to provide manufacturers with free scientific guidance on orphan status qualification, clinical evidence requirements, and post-market follow-up planning.
- Incentives and prioritisation – A proposed framework enabling the designation of “priority diagnostic devices” in cases where high clinical value is anticipated, accompanied by regulatory incentives such as shorter review timelines, reduced fees, and financial support during the clinical development phase.
Definition and qualification – the need for precision
The document stresses the importance of standardizing and refining the definition of an “orphan IVD”. Suggested criteria include the estimated number of patients within the EU, the absence of alternative diagnostic methods, and clear clinical benefit demonstrated by the device. Team-NB recommends that such qualification be carried out by the European Commission in collaboration with MDCG experts, following a process analogous to the EMA’s orphan designation for medicinal products.
Role of Notified Bodies and next steps
Team-NB emphasizes that Notified Bodies are prepared to support the implementation of these proposals and urges the European Commission to promptly begin work on the necessary legislative instruments. The authors of the paper also stress that the proposed solutions should be embedded within the existing IVDR framework—not established as a separate system—which will require amendments to implementing acts and MDCG guidance.
