The regulatory position on fluorescein strips

Medicines regulatory news 30 December 2013

Following the discontinuation of Fluorets strips by Bausch & Lomb earlier this year, the MHRA has received a number of queries about the regulatory classification of fluorescein strips.

The MHRA's position is that fluorescein strips intended for diagnostic purposes are regarded as medicinal products because they are in vivo diagnostic agents. Therefore they need a marketing authorisation under the requirements of the medicines legislation if they are intended for diagnostic purposes.

These strips, if intended and marketed only for the fitting of contact lenses, can be CE marked as medical devices, but the manufacturer should not describe such products as suitable for diagnostic purposes.

The regulatory classification of this category of products is currently being considered at European level.

However, to avoid shortage of supply, the MHRA will not take formal regulatory action to stop these products with a CE mark being used for diagnostic purposes until a decision about these products has been made at European level.

There are no restrictions on the sale and supply of medical devices, therefore practitioners can use a product which has been CE marked as a medical device.