Euromcontact has called on EU member states to be “pragmatic” and allow fluorescein strips on the market as medical devices until their classification is concluded in the Borderline & Classification Expert group. Failing to do so would have a major impact on the availability of such products, impacting European patients, eye-care professionals and contact lens manufacturers, said the organization.
Euromcontact, which represents the European contact lens and lens-care industry, supports the classification of this product, used for the fitting of contact lenses, as a medical device.
Availability of fluorescein strips for the fitting of contact lenses has been discontinued in some member states because the local classification guidelines for medical devices or medical products are not clear. Some suppliers have decided to stop placing these products on the market to avoid any regulatory issues. Their unavailability can have a negative effect on patients who are using contact lenses, Eurocomcontact says.
In the U.K., authorities stated at the end of last December that to avoid shortage of supply, they will not take formal regulatory action to stop fluorescein strips with a CE mark being used as medical devices until a decision about these products has been made at the European level, a position that was welcomed by Euromcontact.
Euromcontact also calls on the Commission Borderline and Classification Expert Group to classify these products for their intended use as medical devices and not medicinal products. As medicinal products, European and third-countries' manufacturers would probably stop pr oduction due to the high and costly administrative procedures usually associated with the related authorizations.
Euromcontact is the acronym for the European Federation of National Associations and International Companies of Contact Lens and Lens Care Manufacturers.
Its members include national associations of manufacturers representing the Netherlands, France, Germany, Italy, Spain, Switzerland and the U.K., as well as the global companies involved in the sector - Alcon, Amo, Bausch & Lomb, Ciba Vision, CooperVision, Johnson & Johnson Vision Care and Menicon - and the European Federation for the Contact Lens Industry (EFCLIN).