MDCG 2024-10 Clinical evaluation of orphan medical devices
This document provides guidance to manufacturers and notified bodies on the clinical evaluation pursuant to the Regulation (EU) 2017/745 on medical devices (MDR) of medical devices and accessories for medical devices that qualify as ‘orphan devices’ (OD) and medical devices and accessories for medical devices that have an orphan indication, within the meaning of this guidance.
This guidance is relevant to devices across all risk classes as per the classification rules defined in the MDR. This guidance gives particular attention to the clinical evaluation and investigation requirements stated in MDR Chapter VI and Annex XIV for these devices.
What does this mean to you?
- MDCG 2022-13 Revision 1 can be used as a reference to see how Notified Bodies are designated.
- MDCG 2022-04 Revision 2 is of interest if you have medical devices that have a notified body certificate under the directive and that is making use of the transitional provisions captured in Article 120 of the MDR. This guidance addresses how notified bodies should oversee legacy medical devices certified under the former Medical Devices Directive or Active Implantable Medical Devices Directive.
- MDCG 2024-1-5 DSVG 05 is of specific interest for manufacturers of Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence to harmonise their vigilance reporting.
- MDCG 2024-10 is relevant to medical devices and accessories for medical devices that qualify as orphan devices and medical devices and accessories for medical devices that have an orphan indication.
About the Author
MSc Biomedical Sciences · Director Authorised Representative Services & Manager IVD – Regulatory Affairs
With over 20 years of experience in the diagnostics industry, Kirsten leads the IVD Regulatory Affairs business unit at QbD Group, guiding regulatory strategy and compliance across all IVDs with a focus on companion diagnostics.
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