After months of doubt over the classification of fluorescein strips following Bausch+ Lomb’s discontinuation of Fluorets, the Medicines and Healthcare Products Regulatory Agency (MHRA) has issued further clarification on their use.
The view of the agency, reassuring practitioners they can use CE-marked fluorescein strips, had been sought by the General Optical Council since its own guidance in September last year (News 27.09.13).
A statement said: ‘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. 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.’
To avoid shortage of supply, the MHRA said it would not take formal regulatory action to stop products with a CE mark being used for diagnostic purposes until a decision about the products has been made at European level – something which the regulator said was currently being discussed.
Euromcontact, the voice of European contact lens and lens care industry, welcomed the position of UK authorities and called on other countries to ‘act with pragmatism when considering the use of fluorescein strips’. It follows the discontinuation of availability in some European Member States due to classification uncertainty.