The European Association Of The Contact Lens And Lens Care Products .



Words from the PresidentThe overall goal of Euromcontact is to contribute to bettereye health and vision in Europe, while providing technicalexpertise to decision-makers and professionals. Thisincludes continued efforts to support compliance whenusing contact lenses and their care products, mainlythrough education of Eye Care professionals (ECPs) andpatients. In parallel, Euromcontact provides technicalexpertise to EU decision-makers on the egulatoryframework and its implementation to support the placingon the market of innovative, safe and high qualityproducts.Nicoletta LosiEUROMCONTACT PresidentElected at the General Assembly of 4th May 2017

WHAT ISEUROMCONTACT ?EUROMCONTACT REPRESENTS THEEUROPEAN MANUFACTURERSOF CONTACT LENSES AND LENSCARE PRODUCTSto EU institutions, stakeholders and thetrade press, providing expertise forpolicy-makers and helping shape theright regulatory environment.Our members make society healthierwhile providing safe, high qualitycontact lenses and lens care products,thus contributing to improved eyehealth and vision.Euromcontact members are nationalassociations, individual companiesfrom across Europe and the EuropeanFederation of Contact Lens and IOLIndustries. (EFCLIN).

Soft Contact Lenses(95% of market)Rigid Contact Lenses(5% of market)Contact Lens Care Europe11,000 peopleare directly employedin the sectorTotal value ofcontact lens production is 1.2 billionat industry to Eye CareProfessional levelEuropean Economic Area (EEA)Contact Lens turnoveris approximately 1.3 billionThe Contact Lens (CL) and Contact Lens Care (CLC)product industry in Europe has operations(manufacturing, logistics, marketing and/or sales)in ALL of the 28 European Union and in ALL of the 32European Economic Area Switzerland countriesMarketing, Manufacturing & Logistics OperationsMarketing Operations OnlyMarketing & Manufacturing OperationsMarketing & Logistics Operations

OUR GOVERNANCEOur association follows its internal rules andby-laws, is transparent and open. Its work is basedon strengthening the representation andawareness of the European contact lens and lenscare products industry, allowing it to pursuecommon interests and to establish frameworkconditions for a successful future.Euromcontact by–laws and internal rules are freeto download from the website. Euromcontact isregistered with the EU Transparency Register. Allmeetings are governed by the anti-trust legislationEuromcontact is a recognised industry stakeholderand has seats at all the Working groups set up bythe European Commission, especially in the area ofmedical devices.Euromcontact activities are organised throughworking groups.There are currently four working groupswithin Euromcontact:Regulatory Affairs Focus GroupStatisticsCompliancePublic Affairs Up to 2 delegates per companiesor per association per working group Chair of WG reports to the Board Work of WG driven by expertsTECHNICAL EXPERTISE TO THE EUCommission Working Groups where Euromcontact is an industry observer member : Medical Devices Expert Group Working group on Vigilance Working group on Clinical Evaluation and Investigation Classification and Borderline Working Group / Software Borderline Working Group Eudamed –UDI Working Group and Task force on UDI Medical Devices Expert group of International Medical Devices Regulators Forum (IMDRF)Additionally, Euromcontact is invited to the meetings of the Notified Bodied for MedicalDevices (NB MED)Euromcontact will apply to be an industry observer member of the new Medical DevicesCoordination Group (MDCG) and its Working Groups.

OUR NETWORKEuromcontact is a member of the EuropeanContact Lens Forum (ECLF) - www.eclf.euEuromcontact is a member of the European CoalitionFor Vision - www.ecvision.euThe European Contact Lens Forum (ECLF) is the exchangeplatform between all contact lens specialists and thecontact lens / lens care industry. It consists of the EuropeanContact Lens Society of Ophthalmology (ECLSO); theEuropean Council of Optometry and Optics (ECOO); theEuropean Federation of Contact Lens Industry and IOL(EFCLIN) and; the Euromcontact and InternationalAssociation of Contact Lens Educators (IACLE).The European Coalition for Vision is an alliance ofprofessional bodies, patient groups, European NGOs,disabled people’s organisations, trade associationsrepresenting suppliers and research groups. The ECVexists to raise the profile of eye health and vision, to helpprevent avoidable visual impairment, and to secure anequal and inclusive society for those with irreversibleblindness or low vision in Europe, usually through eventson the World Sight Day.ECLF meets twice a year to exchange information, identifycommon interests and decide on joint activities. A series ofdocuments and infographics to help compliance targetingECPs and contact lens wearers are available on-line.

WHAT’S IN ITFOR YOU?Euromcontact provides an open and equal platform for members of allsizes for the exchange of information and promotion of action whereappropriate. Euromcontact uses advocacy to achieve its goals,including coalition building and constructive dialogue with relatedassociations and political authorities (European Commission;Competent authorities of Member States; Parliament).Euromcontact membershipaffords access to: Unique platform for exchange amongstmanufacturers; Access to working group meetings a unique setto exchange amongst experts on commonissues; Regulatory documents, training and seminarson regulatory affairs issues; Detailed market statistics; Proposed Code of Conduct for associationsand for companies; Regular newsletters reporting on theassociation’s activities and latest developmentsin the EU arenaNotified Bodies’Association NB TEAMhas dialogue with :Medtech EUEuropean Councilof Optics andOptometrists ECOOCompetentauthorities onmedical devicesThe European Commission,Directorate General GROWResponsible for medical devicesThanks to Euromcontact you can: Gain expertise into the political issues impacting your industry; Help shape the industry position and influence the decision-making process; Have a direct say in Brussels.

PRIORITIES1A EU regulatory environment thatsupport marketing of safe, high qualityand innovative products on the marketEuromcontact is committed to sharing itstechnical expertise and knowledge with EUdecision-makers for the smooth implementationof the medical devices regulation.Euromcontact will continue its efforts to educateand provide training to its members on the newregulatory framework. Additionally the ClinicalEvaluation Document of Euromcontact, aimed atproviding a framework for companies to run theirclinical investigation and evaluation, is alsoupdated on a regular basis and in line with thelatest version of Clinical Meddev 2.7.1/rev4.2Statistics on the market for softcontact lens and lens care productsSince 2003 Euromcontact has provided amarket report for soft contact lens and lens careproducts. The report is based on aggregateddata collected by an independent company fromcontributing companies. The level of detail in thereport varies depending on whether the recipientis a distributing company, a national associationor the trade press. The statistics collection andreporting will continue to provide toprofessionals an accurate picture of the marketfor soft contact lenses and their lens careproducts.

3Promotion ofcontact lensesEuromcontact’s objective to promote the use ofcontact lenses is the basis for its activities.Euromcontact national associations are active atnational level through the organisation ofexhibitions, congresses and seminars targetingeye care professionals; through social media andpress campaigns targeting patients; etc.Euromcontact is present in the main internationaland European congresses on contact lenseswhere it provides information on the market, ofthe activities of the associations and of itsmembers.4Patient compliancewith contact lensesEuromcontact is committed to contributing topatient contact lens compliance. In collaborationwith ECPs within the European Contact LensForum, Euromcontact contributed to thedevelopment of recommendations addressed topatients and ECPs on how to handle and takecare of contact lenses, as well as what to dowhen their ECP on a regular basis.

MembersContactEUROMCONTACT aisbl10 rue de Tamines1060 Brussels-

Soft Contact Lenses (95% of market) Rigid Contact Lenses (5% of market) Contact Lens Care Europe 11,000 people are directly employed in the sector Total value of contact lens production is 1.2 billion at industry to Eye Care Professional level The Contact Lens (CL) and Contact Lens Care (CLC) product industry in Europe has .