PRESS RELEASE: German DQS grants CE mark to FluoGP fluorescein strip (PDF)
28th March, Brussels – The German notified body DQS announced it will grant the CE mark to the FluoGP fluorescein ophthalmic strip.
The German competent authority DQS decided it would grant the CE mark to the small molecular weight fluorescein strip FluoGP, to be used for contact lens fitting. This means it is recognizing the product as being a medical device, and that German manufacturers can proceed with its production. It will nevertheless take approximately two months for it to become available.
The DQS has also confirmed the CE marking of the already existing large molecular weight fluorescein strip – FluoSoft.
In the context of the current debate over the classification of fluorescein ophthalmic strips as medical devices or medicinal products at the level of the European Commission’s Expert Group, the decision by the DQS is a welcome signal.
Notes to editors
- The European Council of Optometry and Optics (ECOO) is the European organisation which represents the interests of optometrists and opticians from 26 countries. It aims to promote eye health to the public across borders and to harmonise clinical and educational standards of optometric and optical practice throughout Europe.