New Publication from Team-NB on Orphan IVD Devices

On 17 July 2025, Team-NB, the European Association of Medical Devices Notified Bodies – released a comprehensive position paper on Orphan In Vitro Diagnostic (IVD) Medical Devices under the EU In Vitro Diagnostic Regulation (IVDR). While the IVDR provides a robust framework for performance and clinical evaluation, it currently lacks specific provisions for IVDs intended for rare diseases, creating challenges for both manufacturers and notified bodies.

Key Highlights

• Proposed Definition: An Orphan IVD is defined as a device intended for the diagnosis or monitoring of diseases with a prevalence of ≤1 in 2,000 individuals in the EU, where no appropriate alternatives exist or where the device offers an added clinical benefit.

• Performance Evaluation: Orphan IVDs may face justified limitations in pre-market clinical evidence due to the rarity of the conditions. Team-NB supports a flexible and proportionate approach, emphasizing robust post-market performance follow-up (PMPF) plans and the use of real-world data.

• Data Sources: Clinical evaluation may draw on diverse sources, such as legacy device data, off-label use evidence, expert opinions, registries, and retrospective case reports. Pre-market limitations can be mitigated through structured post-market activities.

• Regulatory Pathways: Notified Bodies are encouraged to issue conditional certificates when pre-market clinical evidence is limited, provided that clear follow-up requirements are established. Collaboration with expert panels is supported for determining orphan status and clinical strategies.

• Multiplex and In-House IVDs: Orphan status is device-specific; multiplex assays and in-house manufactured tests are treated separately but may contribute supportive data if appropriately justified. 

Why it Matters 

This position paper provides clarity on how Notified Bodies intend to assess Orphan IVDs, aiming to facilitate access to essential diagnostics for rare diseases while maintaining the stringent regulatory requirements under the IVDR. 

For more information, click here to read the Full Position Paper (PDF) 

How MedEnvoy Can Help 

Our team supports manufacturers in the assessment and justification of Orphan IVD device status, development of tailored PMPF strategies, interaction with expert panels, and preparation for notified body review. 

For tailored support or a strategic regulatory assessment of your IVD portfolio, contact our regulatory experts.