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European Council of Optometry and Optics

ECOO

ECOO's vision is to improve vision and eye health by providing high-quality, cost-effective optometric and optical services across Europe.

Lobbying Activity

Response to EU label on product durability and EU notice on consumers’ legal guarantee rights

28 Jul 2025

The European Council of Optometry and Optics (ECOO) recommends that optical retailers, who operate as health-focused service providers, be exempted from the obligations set out in the proposed Implementing Regulation on harmonised consumer guarantee notices and commercial durability labels (Annexes I and II). SECTOR OVERVIEW Optical retailers differ fundamentally from typical consumer goods sellers. Rather than offering standard, off-the-shelf items, they primarily deliver adaptable medical devices, such as prescription eyewear, tailored to the specific clinical needs of individuals. This dual role, part retail, part healthcare, makes optical services structurally and legally distinct from conventional retail models. RATIONALE FOR EXEMPTION 1. MISMATCH WITH LEGAL AND PRACTICAL REALITIES The consumer transactions in optical retail often involve a combination of sales and bespoke services. Guarantee rights vary depending on whether a product is sold ready-made or customised for the individual. The simplified and uniform legal guarantee notice under Annex I does not account for these distinctions. In many cases, it will either misrepresent the consumers rights or create misunderstanding. This risks undermining consumer trust and increasing the need for clarification at the point of sale, placing unnecessary pressure on staff and service flow. 2. PRODUCTS COMPRISED OF MULTIPLE COMPONENTS A typical pair of spectacles includes two main components, frames and lenses, which are often supplied by different manufacturers, each with their own warranty conditions. Frames are usually visible and displayed in-store, while lenses are ordered and customised individually. If a consumer sees a label on the frame (as proposed in Annex II), they may assume it applies to the entire product, which is not the case. This could lead to significant confusion regarding which parts of the product are covered by which warranties. 3. PRACTICAL CONSTRAINTS ON LABELLING The majority of products on display in optical shops, particularly spectacle frames, are small, lightweight, and presented unpackaged. The proposed label size of 95 x 100 mm is disproportionately large in relation to these products. Applying such labels would not only be impractical but would also reduce the number of items that can be displayed, limiting consumer choice and affecting the visual layout of shops. 4. EXCESSIVE ADMINISTRATIVE BURDEN ON A LABOUR-INTENSIVE SECTOR Optical retail across Europe is dominated by SMEs, with relatively few staff per store. These businesses are already under increasing pressure to meet rising demand for vision correction, particularly in light of an ageing population. Moreover, optical services are subject to strict compliance with data protection and medical device regulations. Adding further labelling and documentation requirements would impose a significant new burden, diverting resources away from essential patient care and product safety processes. CONCLUSION Optical professionals do not operate as standard retailers; they provide health-related services and supply highly individualised medical products. The guarantee and durability labels outlined in Annexes I and II are not fit for purpose in this context. Instead of promoting transparency, they risk misleading consumers and creating inefficiencies in service delivery. ECOO calls on EU policymakers to exempt optical retailers from these labelling requirements. This exemption would help preserve clarity for consumers, reduce unnecessary administrative complexity, and support the continued delivery of accessible, high-quality vision care across Europe.
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Response to EU rules on medical devices and in vitro diagnostics - targeted evaluation

21 Mar 2025

As the European umbrella association representing the interests of optometrists and opticians across Europe, the European Council of Optometry and Optics (ECOO) fully supports the objectives of the MDR to ensure that medical devices placed on the market are safe. Opticians and optometrists prescribe and supply medical devices as part of their professional service, ranging from spectacle frames, lenses, contact lenses, non-corrective contact lenses as well as relevant eye care solutions. For this reason, ECOO has been part of the MDCG working groups since their establishment and has been an active stakeholder during the implementation process of the MDR. ECOO now welcomes the opportunity to provide feedback to the evaluation of the MDR and is providing detailed feedback on the following topics in the attached file: - Terminology: Opticians and optometrists are responsible for prescribing and dispensing visual aids to consumers/clients and therefore they need to fulfil the obligations of a distributor as per the MDR. However, the terminology of distributor has caused confusion in a number of countries because the services provided by primary eye care providers (ECPs) go beyond the mere distribution of a medical device. - Adaptable Medical Devices: Corrective spectacles are composed of a frame and ophthalmic lenses. Both the frame and the lenses are classed as medical devices. However, the MDR does not make provision for spectacles once the two separate devices are assembled. They cannot be interpreted as a custom-made device nor are they a medical device in their own right. Once this problem became apparent, Member States decided to classify spectacles as an adaptable medical device, as defined by the IMDRF (International Medical Device Regulator Forum). However, this has no formal legal basis. ECOO therefore considers that it is important to provide clarification within the MDR so that an adaptable medical device falls within the proper legal framework and is not just defined in a non-binding Q&A document. - Master UDI: A Master UDI system has been defined for contact lenses so as to reduce the number of entries into EUDAMED. It will be important to keep this system stable and to avoid unnecessary changes. A proposal for Master UDI for spectacle frames and lenses has also been proposed. Originally, given the high volume and very low risk for spectacle frames and ophthalmic lenses, we suggested that these devices should be exempted from UDI requirements, as we understand is the case in the USA. This could not happen because no provision for an exemption exists in the MDR. We would therefore suggest that this should be revisited in the current evaluation. However, if the requirement for UDI for all devices regardless of risk is retained, it is important to implement this in as straightforward a manner as possible and the proposed Master UDI scheme for spectacle frames and ophthalmic lenses should be adopted. - Disproportionate burden on manufacturers: As outlined in the submission of EUROMCONTACT, the MDR imposes substantial documentation and reporting burdens, particularly for legacy devices with long-standing safety records, without adding clear patient safety benefits for these devices. - Annex XVI products: Contact lenses without a medical purpose are covered by Annex XVI. ECOO would like to express concern that plano contact lenses (i.e cosmetic lenses that are coloured or with patterns) are still available on the EU market without CE marking, which raises concerns as to how effectively the MDR is implemented in this area. - Digitalisation: As increasingly more documentation is available in electronic format, which in general is more convenient for patients as well as being more environmentally sustainable, ECOO supports the expansion of electronic instructions for use (eIFU) to the end-user, in particular for contact lenses.
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Response to Implementing regulation for electronic instructions for use for medical devices

21 Mar 2025

The European Council of Optometry and Optics (ECOO) welcomes the opportunity to provide comments on the draft Implementing Regulation aimed at expanding the scope of electronic instructions for use (eIFU) for medical devices. In 2024 opticians and optometrists throughout Europe responded to the EU Commissions survey on eIFU. The response rate was very good and 90% of the 7,300 healthcare professionals who responded agreed that eIFU could be provided for additional medical devices intended for lay users. The benefits highlighted include patient-centered approach, patient safety, compliance, and autonomy. We were therefore surprised to see that the eIFU remains limited to medical devices intended exclusively for use by healthcare professionals, and also excludes products listed in Annex XVI of the MDR, as well as medical devices and accessories used by non-professionals, such as contact lenses and lens care products. In addition to the arguments presented by healthcare professionals, we believe there is a strong sustainability consideration here, by reducing the use and waste of paper, which is not wanted or needed by the end user. We believe that for most patients, eIFUs are all that is needed. But if a more cautious approach was wanted, there could be a requirement to provide a paper version only for first-time contact lens users if requested. eIFUs also have the advantage that they can be more easily updated and they can be made more user-friendly (e.g. ability to increase font size for easier reading). We would also highlight that EuromContact conducted a survey in 2023 via OpinionWay of 1,008 contact lens wearers in the European Union. This found that 85% of respondents preferred eIFU for their contact lenses and lens care products. Additionally, the 2024 European Patients Forum (EPF) survey on the implementation of the EU MDR found that digital information is becoming increasingly the norm and that increased availability of eIFU for patients is helpful, as long as paper-based instructions remain available, to avoid inequalities in information access. We hope that these aspects can be taken into consideration in the relevant MDCG discussions to ensure that the EU stays abreast of developments and trends in digitalisation in this area.
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Meeting with Karima Delli (Member of the European Parliament, Rapporteur) and European Transport Safety Council and

1 Jun 2023 · Driving Licence Directive

Response to Revision of the Directive on Driving Licences

23 May 2023

The European Council of Optometry and Optics (ECOO) supports the objectives of the Driving Licence Directive, and the two primary objectives behind the current proposed revision of the Driving Licence Directive: to improve road safety and to facilitate free movement by removing or avoiding unnecessary or inadequate barriers. The Directive, supported by Annex III on medical fitness to drive, provides important and proportionate safeguards, which help protect all European citizens, including pedestrians and cyclists as well as drivers. Our purpose in contributing to this review is to ensure that the requirements that are included in the Directive and Annex III are clear and consistent, in order that they can be consistently applied across all member countries. It is also important that terms used are consistently applied across all EU regulations. Unfortunately, this has not been the case with the current Directive to date. To be clear, our comments do not suggest any increase or extend in the scope of requirements of the Directive or Annex III. In reviewing the draft Directive and Annex III we have identified a few areas in the proposed revisions that are not clear enough. We therefore suggest a number of clarifications to Annex III on the eyesight requirements (please refer to the attachment for full details): Point 3 of Annex III makes clear that applicants must demonstrate that they meet with medical requirements for fitness to drive on both application for and renewal of a driving licence. It is therefore inconsistent and/or confusing not to make clear that the eyesight requirements also apply both on application and at renewal. The regulation of professions, including their scope of practice, is a national competence and governed by national law and not by an EU Directive. We therefore propose the addition to the text in Annex III, point 6 by a qualified eye care professional authorised by national law to ensure that professionals who by national law are authorised to carry out visual assessment for fitness to drive will continue to be allowed to do so and will not encounter difficulties due to confusions caused by the wording in the EU Directive. This will ensure that national law prevails on a matter that is in fact a national competence. This change does not create or suggest any extension or reduction in the scope of practice of any professional group. This is also the wording used in other EU legislation, such as the Medical Devices Regulation. We suggest clarifying in Annex III, point 6 that visual acuity is measured by means of a validated visual acuity chart because it is a core established measure of visual function and the only accurate way to measure visual acuity. Other methods, such as the Licence Number Plate Test, do not actually measure visual acuity and are not carried out in standardised conditions, they thus do not meet the requirements nor the objectives of the Directive. The visual requirements laid out in the sections headed Group 1 and Group 2 are expressed without indicating the method of measurement. There are in fact two different methods of measuring visual acuity that can be expressed as a decimal; that is decimal notation and the LogMAR equivalent. Annex III should ideally include both methods of measurement. However, at a minimum it needs to be clear as to which method it is currently using, we therefore suggest to clarify that decimal notation is the measurement used in the Directive.
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Response to Unique Device Identification assignment for highly individualised devices

18 Apr 2023

The European Council of Optometry and Optics (ECOO) represents the interests of optometrists and opticians across Europe including contact lens specialists, many of whom operate as SMEs. ECOO notes the provision in the draft Delegated Regulation to create an alternative structure to current UDI-DI standards by grouping all contact lenses with clinical similarities under a new identifier called Master UDI. As eye care providers we are concerned about the additional burden that this new system would create, especially for SMEs, particularly in terms of scanning devices and software requirements. At present, the clinical size information is available in an easy-to-read format for both the patient and health care provider via labelling and accompanying documentation. Retrieving data via the barcode would create an unhelpful complication because it would require the user to download the necessary application to read the barcode, scan it and correctly interpret the results. Moreover, this decoded data would not correspond to the format of the patients prescription. We also believe that the use of a Master UDI would complicate the understanding of any patient-related issue when there is a complaint because the lens characteristics would be split between the Master UDI and UDI-PI. If a consumer complained via the database, then the eye care practitioner would be missing a considerable amount of data that would be needed to be able to identify the exact contact lens. This is because the draft delegated act foresees the inclusion of four parameters (power, cylinder, axis and add power) in the Master UDI. However these four parameters would not enable the unequivocal identification of the device. With these four parameters the consumer and eye care practitioner would in fact be presented with more than a dozen products without differentiation. To identify the actual device, the health care provider would need to combine a number of sources instead of one, with the risk of confusion i.e. greatly complicating the process. In practice it is far more important to have the data on the substrate material and production parameters such as base curve, diameter and product name. From a consumer and eye care practitioners point of view, the order of relevance is the following: manufacturer, product name, lens type, lens material, and only then the clinical parameters. In terms of multifocal contact lenses even more data needs to be considered to identify the product properly. We therefore suggest standard contact lenses should continue to use UDI-DI, as is the case for any other medical device covered by article 27 of the MDR. Made to order contact lenses should continue to be assigned a UDI-DI by model (which includes brand, raw lens material, geometry, and package quantity) to allow its registration in EUDAMED and labelling. In the event that the high volume of contact lenses poses a problem to the system, a higher-level grouping identification for contact lenses could be included in the UDI barcode as an additional identifier, to enable EUDAMED registration.
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Response to Revision of statistical classification of economic activities

8 Sept 2022

We are concerned that the annex to the draft delegated regulation amending Regulation (EC) No 1893/2006 of the European Parliament and of the Council of 20 December 2006 establishing the statistical classification of economic activities does not currently include optometric and optical eye care services. This would be a significant omission in the health care section of these statistics. We therefore call for the addition in section R, division 86, group 9 of: 86.98 Optometric and optical activities (provision of eye care services). Optometrists and opticians are healthcare professionals delivering primary eye care and associated services. These services are almost entirely delivered in the community in optical practices. Visual impairment and eye health problems put significant pressure on health systems. With growing and ageing populations, lifestyle factors such as obesity on the rise and the increase in the prevalence of myopia, demand for eyecare will expand. The Covid-19 pandemic has highlighted the need for health authorities to make best use of all healthcare resources and professionals available to them. In many Member States optometrists and opticians where important in helping to reduce the pressure on other parts of the healthcare system. It is therefore essential that statistical data on the provision of these services and the contribution of all providers of these essential health services is available to policy makers and health planners. Furthermore, we would highlight that the 2014 Report of the Expert Panel on Effective Ways of Investing in Health (EXPH) defined primary care as “the provision of universally accessible, integrated person-centred, comprehensive health and community services provided by a team of professionals accountable for addressing a large majority of personal health needs” and went on to list the professionals active in primary care teams, including optometrists. (Pages 18 and 49, https://ec.europa.eu/health/system/files/2019-11/004_definitionprimarycare_en_0.pdf) The World Health Organisation has also recognised optometry as a primary care profession, most recently in the World Report on Vision (https://www.who.int/docs/default-source/documents/publications/world-vision-report-accessible.pdf) It would therefore be a major omission not to include in such important data collection a healthcare profession, which provides primary care services in many countries in much the same way as do dentists and physiotherapists, who are included in the annex. It would also be inconsistent with the accepted definition of primary care agreed by the EXPH. We have attached the ECOO Blue Book (https://ecoo.info/ecoo-blue-book/), which provides fuller data on the scope of practice of optometrists across Europe, including their role in providing state funded, primary care.
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Response to Statistics on health care facilities, health care human resources and health care utilisation

20 Jun 2022

We are concerned that the annex of definitions currently omits optometrists and opticians, which suggests that these important providers of primary care will not be included in EU statistics on healthcare facilities, staff and the use of services. Optometrists and opticians are healthcare professionals delivering primary eye care. This includes comprehensive care of the eyes and the visual system. In many countries they are the first point of contact for people with eye and vision problems. This includes the examination of the eye which can detect pathological conditions and includes diagnosis, treatment management and referral. The scope of practice of optometry and optics varies between countries and the extent of available training, the organisation of the profession and the relative size of the ophthalmology sector are determined by the national law in Member States. Optometry is associated with primary care in many Member States. While there are some Member States where this is not the case, the scope of practice of optometrists and opticians is evolving and increasingly more countries recognise their role within and importance to the healthcare system. Visual impairment and eye health problems put significant pressure on health systems. With growing and ageing populations, lifestyle factors such as obesity on the rise and the increase in the prevalence of myopia, demand for eyecare will expand. The only way to meet these challenges is to recognise and invest in a strong and well-trained optometric workforce that can ensure timely diagnosis of eye conditions and access to care. The Covid-19 pandemic has highlighted the need for health authorities to make best use of all healthcare resources and professionals available to them. In many Member States optometrists and opticians where important in helping to reduce the pressure on other parts of the healthcare system. In Ireland, for example, optometrists were trained to deliver Covid-19 vaccinations. Furthermore, we would highlight that the 2014 Report of the Expert Panel on Effective Ways of Investing in Health (EXPH) defined primary care as “the provision of universally accessible, integrated person-centred, comprehensive health and community services provided by a team of professionals accountable for addressing a large majority of personal health needs” and went on to list the professionals active in primary care teams, including optometrists. (Pages 18 and 49, https://ec.europa.eu/health/system/files/2019-11/004_definitionprimarycare_en_0.pdf) The World Health Organisation has also recognised optometry as a primary care profession, most recently in the World Report on Vision (https://www.who.int/docs/default-source/documents/publications/world-vision-report-accessible.pdf) It would therefore be a major omission not to include in such important data collection a healthcare profession, which provides primary care services in many countries in much the same way as do dentists and pharmacists, who are included. It would also be inconsistent with the accepted definition of primary care agreed by the EXPH. We have attached the ECOO Blue Book, which provides fuller data on the scope of practice of optometrists across Europe, including their role in providing state funded, primary care.
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Response to Proposal for a Council Recommendation on long-term care

29 Mar 2022

Looking after vision and eye health is important throughout a person’s lifespan, but it is important to be aware that the risk of vision loss increases with age. Over 73% of people with vision loss are older adults. Without the ability to see, older adults are less able to lead fulfilling and independent lives and, as a result, will be more likely to need long-term care and often higher levels of care. If you can prevent or reduce sight loss a person is less likely to need long term care; and if they do need long term care then maintaining their vision increases their quality of life and can reduce the level of care they require. The actions required to achieve such a change are relatively low cost and straightforward to implement. We call upon the European Commission to include vision and eye health in the European Commission Communication on a European Care Strategy and in its proposal for a Council Recommendation on long-term care. In particular to: - Acknowledge the importance of vision and eye health as part of long-term care. Eye conditions and vision impairment pose a significant personal and societal burden. Surveys have shown that people fear losing their vision more than any other sense Those with preventable vision loss become needlessly reliant on a care system, posing considerable and avoidable costs in health and social care and in lost productivity. But the investment required to address poor vision is a fraction of those losses. It thus makes economic and social sense to give this topic the attention it deserves. - Include the need for adequate regulation and recognition of primary care providers such as opticians and optometrists at national level to ensure the full potential of the workforce is used to achieve the needed access, availability and quality. Primary eye care professionals such as opticians and optometrists are the first point of contact for people to maintain good vision and eye health. The WHO World Report on Vision states that the optometric profession is still not recognised in many countries, notwithstanding the progress made on the training standards for optometrists, optometric technicians and optical technicians. The report points out that the lack of professionals that are accredited to carry out independent eye care services could lead to decreased productivity. This is sadly the case in some Member States, and yet the quality of education and training across Europe means that such restrictions are unjustified. The failure to make effective use of properly trained and competent eye care professionals will have an obvious effect on the access to quality eye care and should be addressed in guidance to Member States and subsequent policy initiatives. - The promotion of regular eye health checks needs to be supported by public policy and awareness. It should be noted in particular that an eye examination does not just check vision, it is also a healthcare check. The back of the eye is the only part of the body where blood vessels and nerves can be assessed through visual inspection and without an invasive procedure. Issues such as diabetes, hypertension and neurological conditions such as multiple sclerosis or brain tumours can be detected through an eye examination. The European Commission should take a leading role in guiding EU Member States to meet their commitment made with the United Nations resolution 73/310 Vision for Everyone: accelerating action to achieve the Sustainable Development Goals. The adoption of the first United Nations resolution on vision explicitly links eye health to over half of the sustainable development goals! Please refer to the attached document from European Council of Optometry and Optics (ECOO), the Global Coalition on Aging (GCOA) and the International Agency for the Prevention of Blindness (IAPB) for an outline of the evidence base. ECOO represents the interests of optometrists and opticians across Europe.
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Response to Common Specifications on products without an intended medical purpose listed in Annex XVI (Medical Devices Regulation)

10 Feb 2022

The European Council of Optometry and Optics (ECOO) is the European umbrella association representing the interests of optometrists and opticians across Europe. Our members are national professional associations from 25 countries who together represent more than 150,000 opticians and optometrists. ECOO aims to promote eye health to the public across borders and to harmonise clinical and educational standards of optometric and optical practice throughout Europe. ECOO’s response to the consultation on the implementing regulation, laying down common specifications for products listed in Annex XVI of the MDR, relates to the provisions for non-corrective contact lenses (Annex II). 1) ECOO would like to highlight that the scope of Annex XVI should be, as foreseen by the MDR, limited to products without intended medical purpose only. This means that devices that exert both a medical purpose and at the same time a secondary non-medical purpose should be excluded from the scope of the Common Specifications. An example would be a corrective coloured contact lens. This lens provides a vision correction (via the refraction) which is clearly a medical purpose. As the refraction is always present and cannot be avoided, this device will always be a medical device and can never be used for a non-medical purpose only. Therefore, the indication ‘also for non-medical use’ is not accurate and would be misleading for patients, hence not ensuring patient safety as coloured and corrective contact lenses cannot be used non-medically. The labelling of the device should clearly indicate that ‘this is a medical device’. Safety of patients is the priority and the message to patients should be clear and avoid confusion. 2) The current draft of the Common Specifications foresees in Article 2 no. 2 that the deadline to place on the market, make available and put into service a product benefiting from the transitional provisions will be the same date. This will result in the impossibility to further make available, for example by a distributor, or even put into service, for example by a user (e.g. patient or hospital), a product lawfully placed on the market close to the deadline. As this will cause supply issues, affecting the eye care professional using/fitting the product, ECOO supports the EUROMCONTACT position, calling on a sell-off provision for devices which have already entered the supply chain before the end of the transitional period. The suggestion is to allow for an additional year to be granted for devices lawfully placed on the market before the end of the transitional period for the ‘making available’ or ‘putting into service’ of these devices.
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Meeting with Astrid Dentler (Cabinet of Vice-President Dubravka Šuica)

7 May 2021 · - Green Paper on Ageing - Eye health in an ageing population

Response to Driving licence legislation ex-post evaluation

3 Sept 2019

The European Council of Optometry and Optics (ECOO) welcomes the European Commission’s initiative to carry out an evaluation of Directive 2006/126/EC on driving licenses. ECOO represents the interests of optometrists and opticians from 24 countries, aiming to raise awareness of the importance of eye health and to harmonise clinical and educational standards of optometric and optical practice throughout Europe. Even though opticians and optometrists are not directly involved in the implementation of the Directive 2006/126/EC, they have an important role to play in improving road safety in the EU, by carrying out relevant eye checks in many countries, encouraging frequent vision checks of drivers and by working towards harmonising driver’s eye health standards across Europe. ECOO would therefore like to stress the importance to include all relevant stakeholders in the upcoming consultations planned by the Commission as part of the evaluation of the Directive, including its annexes.
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