The Medical Device Coordination Group (MDCG) has released a new guidance document, MDCG 2024-10, providing crucial insights into the clinical evaluation of orphan medical devices. These devices are designed to address rare diseases, which often have limited diagnostic or therapeutic options. The guidance aims to harmonize the stringent requirements of the Medical Device Regulation (MDR) with the unique challenges faced by orphan devices, ensuring patients have prompt access to these essential products while maintaining high safety standards.

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Targeting manufacturers and notified bodies, the document provides guidance on the clinical evaluation of medical devices and accessories that qualify as orphan devices or have an orphan indication. It applies to devices across all risk classes as defined in the EU MDR. Excluded are custom-made devices, in-house devices, products without an intended medical purpose, as well as in vitro diagnostic medical devices.

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MDCG 2024-10 considers the need to produce robust clinical data to demonstrate safety and efficacy, as well as the challenges of gathering extensive data due to the rarity of the conditions these devices address.

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Key Highlights:

1. Orphan Device Status & Indications: clarifies the criteria for orphan devices and the justification process, ensuring a clear pathway for devices addressing rare conditions.
2. Clinical Evaluation Considerations: detailed guidance on the pre-market and post-market clinical data requirements, emphasizing the need for robust data while acknowledging the practical limitations in rare disease contexts. This includes focusing on clinical considerations for orphan devices, acceptable limitations in pre-market data, key evaluation considerations, and strategies for generating post-market data.
3. Procedural Considerations: enhances the roles of notified bodies and expert panels in ensuring the safety and efficacy of orphan devices. Outlines specific steps and requirements, including procedural considerations for notified bodies and the crucial role of expert panels in the evaluation process.

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Additionally, MDCG 2024-10 includes three appendices with specific instructions on clinical evaluation reports, clinical investigations, and the extrapolation of clinical data for orphan indications, further enriching its practical application.

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For more detailed information, you can access the full document here.

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