NOVAVISION GROUP

NovaVision Group specializes in intraocular lenses (IOLs) and ophthalmic devices used primarily in cataract and refractive lens exchange surgeries. Their portfolio includes multifocal, accommodative, and toric IOLs—such as DAFNE, ANIKA, and 4PLUS—which are designed to correct presbyopia, astigmatism, and other vision-related conditions. They also produce surgical tools and accessories, like the RADIO4 and AFRODITE systems, which assist in intraocular procedures.

NovaVision Group is based in Italy, where it operates under the European Union’s regulatory framework. Since their devices are classified under EU Medical Device Regulations (Class IIa and IIb), they must comply with EU directives, including registration in the eudamed database—a centralized EU system for tracking medical devices. This ensures transparency and adherence to safety standards across the European market.

NovaVision Group’s devices are registered in the eudamed database, the official EU system for medical device information. This registry is mandated under EU Medical Device Regulations (MDR) and ensures that all listed products meet required compliance standards before entering the market. The inclusion in eudamed reflects their adherence to EU regulatory requirements.

NovaVision Group’s devices are classified as Class IIa and Class IIb under the EU Medical Device Regulations. This classification is based on their intended use and associated risk levels—Class IIa covers moderate-risk devices like certain IOLs, while Class IIb includes higher-risk products requiring stricter scrutiny. The classification determines the regulatory pathway and documentation requirements for market authorization.