21 June 2019

Fluorescein Strips – European regulation debate continues but status-quo remains unchanged for the moment

At the European Council of Optometry and Optics (ECOO) meeting in May 2019, ECOO President Cindy Tromans (also COptom European adviser), who represents ECOO on the EU Borderline and Classification Working Group, reported that fluorescein is not being discussed in the Working Group at present.  Attention has focused instead on the revision of definitions (e.g. the meaning of ‘diagnosis’ etc) under which fluorescein strips may be classified as a medicine.

The European Medicines Agency has now sent the draft definitions to the European Commission, which is in consultation with the Member States.  Once this consultation process ends, there will be a small window of opportunity for ECOO and the UK to engage and seek to influence.  A workshop focusing on case studies is planned on the definitions but it is unclear at the moment whether fluorescein will be among these.

It is not yet clear whether this favours or disadvantages our position that, when impregnated into a paper strip format, this otherwise medicine should be classified as a medical device.  FODO is keeping the situation under close review with our EU partners and regulatory agencies, the MHRA in the UK and the HPRA in the Republic of Ireland.