Q0101 retinal stimulation systems
Notified Body #
- 0344
Internal CECP dossier #
Date of start of the procedure
- 14.04.2026
Field of expert panel
- Ophthalmology
Medical device type
Q0101 retinal stimulation systems
Intended purpose
Restoration of limited visual perception in severely sight impaired persons
with functional optical nerve and retinal ganglion cell layer who have lost
their central vision due to the degeneration of photoreceptor cells caused
by atrophic dry age-related macular degeneration (AMD).
Risk class / type
- Class III
Screening step:
appropriate medical field
/ competence area
- Devices for ophthalmology
Novelty of device
and/or of related clinical procedure
-
Novelty: High level of novelty
Novelty: Procedure is novel