The Medical Device Coordination Group (MDCG) published a new document on June 25th titled “MDCG 2024-10 “Clinical evaluation of orphan medical devices”. This guidance aims to assist manufacturers and notified bodies in evaluating orphan medical devices (ODs) and devices with orphan indications under the MDR (EU Regulation 2017/745).
The document offers a two-part approach:
– Part A: This section focuses on clinical considerations for orphan devices. It addresses limitations in pre-market data that may be acceptable, key factors for evaluation, and strategies for generating post-market data.
– Part B: This part guides notified bodies on assessing orphan devices and the role of expert panels in the process.
Three appendices provide additional resources:
– Appendix A: Specific guidance on clinical evaluation reports for orphan devices.
– Appendix B: Guidance on clinical investigations for orphan devices.
– Appendix C: Guidance on extrapolating clinical data for orphan indications.
This new guidance clarifies the clinical evaluation process for orphan medical devices, potentially improving market access for these essential but niche technologies.
Find out more about our experience with MDCG guidelines at: https://lnkd.in/dreiWTp7