VDCO-News
Interview with Fabienne Eckert
Secretary General of the European Association of Optometry and Optics (ECOO)
The professional journals have been filled in recent months with the news that fluorescein strips may continue to be used by optometrists for contact lens fitting. ECOO's long-running negotiations on the Medical Device Regulation (MDR) have largely been held in technical committees at EU level and discussed with members in the annual ECOO meetings. For many optometrists and contact lens fitters, it is now interesting to learn more about the details of the classification of fluorescein strips as medical devices, as they are of course significantly affected by this good news.
Fabienne Eckert will enlighten VDCO in an interview and present how ECOO member states jointly achieved the classification of fluorescein strips as a medical device for contact lens fitting.
Let's not fool ourselves: Contact lens fitting, assessment of dry eye symptoms and much more is impractical and not possible in the same quality without the use of fluorescein strips.
VDCO: How did it occur that fluorescein strips suddenly became the focus of the Medical Devices Act and when was that?
Fabienne Eckert: In 2001, the non-binding Meddev document mentioned fluorescein strips as an example of a medicinal product. For ten years this went unnoticed and when in 2011 compliance with this guideline was reminded, the fluoreszein question began. The Swiss Agency for Therapeutic Products, Swissmedic, was the first to act and the production of fluorescein strips as a medicinal product was largely discontinued in Europe.
What consequences did this have for opticians and optometrists after 2011?
In 2012, supply problems arose in some countries and a situation was brewing where opticians and optometrists would no longer be allowed to use fluorescein strips if they were only classified as medicinal products. In order to clarify this situation, a first meeting was held on 15 March 2012, a first meeting was held with the European Commission to clarify this situation. The classifications are based on the legal definitions. Accordingly, years of evidence gathering and meetings with the European Commission began to explain the use of fluorescein strips in contact lens fitting and apply them to the definitions. It also became apparent that other definitions, such as 'diagnosis', still needed to be developed.
In 2013, there was a pushback from the European Medicines Agency and decisions were delayed. Why did the negotiations take so long?
The European Commission has asked the European Medicines Agency for an opinion on the classification of fluorescein strips. Based on the definition of a medicinal product, fluorescein strips have indeed been confirmed as a medicinal product in diagnostic applications. There is of course also the definition of a medical device, but this was not part of this discussion, but is very relevant to contact lens fitting. In addition, work started on the definition of a "diagnosis", which would be decisive for the classification. This work at EU level took a very long time and of course also involved the member states. The developments of the European Medical Device Regulation (MDR) started at the same time, which delayed everything again, as all documents and guidelines had to be adapted to the MDR. However, together with EUROMCONTACT, EUROM VI and EFCLIN, we have been active all these years and have always been able to keep the issue on the agenda. We were also able to hold off the possible ban of fluorescein strips as a medical device until there would be an official decision.
What was the key to being able to positively influence developments?
In 2018, ECOO was approved in several MDCG expert groups, including Borderline & Classification. Through this recognition, ECOO gained a greater voice. In 2018 and 2019, ECOO participated in several meetings where the topic of fluorescein was discussed and bilateral meetings were held with member states. In 2019, the first definition of diagnosis was published, ECOO commented on the new Borderline & Classification document under the MDR. After years of negotiations and discussions until 2022, the outcome according to MDCG 2022-5 - Guidance on the delineation between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices, published on 26 April 2022, is that fluorescein strips may only be used for fitting contact lenses. Fluorescein strips intended to assess the integrity of the cornea should not be classified as a medical device.
What have ECOO and its member organisations and associations, of which VDCO is one, learned from this long process?
Lobbying takes a lot of time! In this case, ten years and six ECOO presidents. But experience also shows that perseverance pays off. The crucial thing was to speak with one voice: ECOO at EU level, members at national level. Building relationships with policy leaders, having a good evidence base and building stakeholder coalitions is something that cannot be done without.
The VDCO would like to thank Fabienne Eckert for the insights into the work of ECOO.
If a higher goal is pursued, it makes sense for all institutions to cooperate in this area. The VDCO wants to take this with it for future projects and aims to maintain close cooperation with other associations.
One goal that we can achieve together is the establishment and greater recognition of optometry in Germany among legislators and end consumers.