The Medical Device Coordination Group has issued the MDCG 2024-10 guidance for clinical evaluation of Orphan Medical Devices (ODs). An OD is a device aimed to assist no more than 12.000 patients annually in the EU, providing new treatment, diagnostic, or preventive measures where alternatives are insufficient or non-existent.
The Medical Device Regulation (UE) 2017/745 (MDR) has raised the bar for clinical evidence, creating unique challenges for ODs. This new guidance is a beacon for manufacturers navigating the complex pre-market clinical investigations to ensure safety and performance.
Key Highlights of MDCG 2024-10:
- PART A: Offers insights into the acceptability of pre-market clinical data limitations, clinical evaluation for new and existing devices, plus post-market data generation, including post-market surveillance (PMS) and post-market clinical follow-up (PMCF).
- PART B: Provides procedural guidance for notified bodies and outlines the role of expert panels.
Appendices include:
- OD-specific factors in clinical evaluation reports.
- Considerations for clinical investigations of orphan devices.
- Extrapolation of clinical data to orphan indications.
Developed in collaboration with stakeholders, this guidance ensures a balanced approach in applying MDR requirements to orphan devices.
Read here the whole guidance: CLINICAL EVALUATION OF ORPHAN MEDICAL DEVICES
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