EUROMCONTACT has called on Member States to act with pragmatism by allowing 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 major impact on the availability on the market of such products, hence impacting European patients, eye care professionals and contact lens manufacturers. EUROMCONTACT supports the classification of this product for the fitting of contact lenses as a medical device.
Discontinuation of availability of fluorescein strips, used in the fitting of contact lenses, has been recorded in some Member States. This is due to the fact that the classification of these products as a medical device or as a medicinal product, is not clear. Some producers of fluorescein strips therefore decided to stop placing on the market these products to avoid any regulatory issues. This discontinuation of fitting products can have a negative effect on patients who are using contact lenses.
At the end of December 2013, the UK authorities stated 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 device until a decision about these products has been made at European level. EUROMCONTACT welcomed this position and calls on Member States to act with pragmatism when considering the use of fluorescein strips. Failing to do so would have major impact on the disposal on the market of such product, and in turn, on the European industry of contact lenses.
In addition, EUROMCONTACT calls on the Commission Borderline and Classification Expert Group to adopt a decision to classify these products for this intended use as medical devices and not medicinal products. Should these products become medicinal products, European and third-countries’ manufacturers would very likely stop production due to the high administrative and costly procedures associated with medicinal products market authorisation.
Helmer Schweizer, EUROMCONTACT President stated: “Fluorescein strips are well-established products and have been CE marked as medical devices for many years. The Commission and expert groups of Member States should clearly acknowledge this and allow this classification at their meeting in March 2014. The growing lack of these products on the market would lead to problems for patients, eye-care professionals and contact lens manufacturers. A clear decision on the classification is needed soon.”