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Medical Devices

Orphan Devices: How to Obtain Orphan or Pediatric Medical Device Approval

Wednesday, May 8, 2024
15:40 – 16:40 CEST
Location: B 07 + B 08
Learning Level: Advanced

Description: The transition from the MDD/AIMDD to the MDR has led to the exclusion of numerous devices from the European Union (EU) market, resulting in significant shortages. In response, the European Commission has established a task force aimed at developing new legislative proposals to assist manufacturers in bringing medical devices for orphan and pediatric indications to market.

The primary objective is to transform the collaboration among manufacturers and other stakeholders in the development, approval, and provision of medical devices for orphan or pediatric indications in the EU. Best practices will undergo thorough assessment for their feasibility in integration with the approval process conducted by the Notified Body, encompassing both pre-market and conditional post-market evaluations. The focus will be on all class of devices, class I, II and III.
Legislative details outlining impending changes for orphan and pediatric devices will be elucidated. Scenarios involving limited clinical evidence will be explored, along with strategies to overcome approval process challenges associated with such cases. Anticipated benefits extend beyond the realm of rare diseases to encompass mainstream medical devices facing challenges related to the quantity or quality of clinical evidence.

The medical device landscape is experiencing unprecedented evolution, characterized by emerging indications, biomarkers, and evidence generation techniques facilitated by Real-World Data/Real-World Evidence (RWD/RWE) and Digital Health Technologies (DHTs). The newly established guidelines and operational approaches are essential tools in ensuring the timely development and availability of orphan and pediatric medical devices in the EU.

Learning Objectives:

  • Gain insights into the upcoming changes in European legislation and their impact on the development of medical devices for pediatric and rare diseases.
  • Explore the feasibility and impact of legislations, regulatory guidelines and incentives on the timely availability of devices for pediatrics and orphan diseases.
  • Engage in a discourse on the possibility of identifying best practices and achieving convergence towards compliance with the EU MDR.