How to obtain CE marking for contact lenses
Contact lenses – either soft, hard or semi hard – are a valid alternative to the daily use of glasses. The convenience of getting rid of an annoying weight on the nose and of the constant worry to leave glasses everywhere, make contact lenses the perfect replacement for the vastly used stemmed medical device.
Eyeglasses are a Class I medical device, whereas contact lenses belong to Class IIb. Any liquid or solution for their care also belong to Class IIb.
Like all medical devices marketed in the European Union, contact lenses are also subject to severe controls regulated by the European directive allowing the final user to use the product safely.
Unfortunately, it is easy to find contact lenses on the market without the CE marking or, even worse, counterfeited lenses. In 2018 only, the Italian financial police seized more than one million counterfeited contact lenses, passed off as Italian products, but actually manufactured in other countries and then imported and packaged in Italy.
Being classified in Class IIb, contact lenses should ensure appropriate safety and efficacy, also by the product labelling and a post-marketing surveillance.
Contact lenses manufacturers should submit detailed information regarding the safety and performance regarding the functions, from biocompatibility to clinical assessment and stability.
There is no distinction between corrective contact lenses and cosmetic contact lenses. They should both comply with directive 93/42/CEE and the international norm UNI EN ISO 14534 “Ophthalmic optics — Contact lenses and contact lens care products — Fundamental requirements”.
In order to obtain the CE marking for contact lenses, manufacturers shall require the services of a Notified body designated by a Member States to assess the conformity of these devices. The Notified Body can carry out all the required controls and check the manufacturing system releasing a CE certification and monitoring the manufacturer during the period of validity of this certification, so that they continues to comply with their obligations.
Following the adoption of the regulations, Notified Bodies are now designated directly by the European Commission.
Once the CE marking has been obtained, manufacturers can place it on the devices and market them, keeping the relevant technical dossier updated, based on a suitable conformity procedure.
Foto di Martin Slavoljubovski da Pixabay
