Eyenuk is well-versed in EU medtech regulations, having received a CE mark in 2015 under the medical devices directives (MDD) for its autonomous EyeArt artificial intelligence (AI) eye screening system to detect diabetic retinopathy.
More recently, the Californian digital health firm has had to grapple with the transition to the EU’s stricter Medical Device Regulation, under which the screening device had its indication expanded to include the detection of