Several years ago, European authorities modified their definition of what is a medical device. With this new definition, coloured ophthalmology diagnostic strips were excluded.
Only devices with a mechanical action were accepted as medical devices, whereas coloured strips would have a chemical action, through a colouring agent combining with various cells. Therefore, coloured strips were to be considered as a pharmaceutical product and, as such, follow the same registration procedure as all pharmaceutical products, together with the drastic trade rules of the same.
Economically, such a process was unbearable, considering the disproportion between market size and cost of procedures. None of the strip producers decided to invest in the legal registration of products which had shown, over the years, to be both very useful and totally harmless. Thus, eye specialists were left unequiped.
Voices raised among them, once they were deprived from these precious diagnostic tools. Discussions were held with referring European authorities which eventually resulted in a possible CE certification for fluorescein coloured strips for the sole indication of « adaptation of rigid contact lenses ».
Registration and control procedure of the product was strengthened, ensuring prescribers, users and patients that fluorescein strips can be used again on human eye, with no danger and even less thane ver.
We are happy to announce that we are now able to provide our customers and all ophthalmology professionals with duly CE certified fluorescein diagnostic strips.