European Alliance for Vision Research & Ophthalmology

Third EU Health Programme

European Open Science Cloud

The European Open Science Cloud (EOSC) is a network of organisations and infrastructures from various countries and communities that supports the open creation and dissemination of knowledge and scientific data.  The EOSC is part of the European Commission’s strategy to open up European research and innovation systems as expressed in the policy initiative Open Innovation, Open Science and Open to the World.

Antimicrobial Resistance (AMR)

In 2016 a new Thematic Network on Antimicrobial Resistance (AMR) was established to engage a diverse group of external partners around this topic and work together on a consensus basis in relation to the content of the new EU One Health Action Plan against AMR. The Thematic Network is led by the European Public Health Alliance (EPHA) and it has launched a Joint Statement and Call to Action on AMR in November 2017.

For more information:
EU Action on Antimicrobial Resistance-Background

Joining the AMR campaign The EU EYE has joined the AMR campaign and call for action led by the European Public Health Alliance: EPHA View here

Medical Devices, In Vitro Diagnostics and Eudamed

Two new regulation for Medical Devices and In Vitro Diagnostics (IVDs), which will apply from 2020, mandate that devices will become fully traceable and that key product information must be given to patients. An expansion of the European Databank on Medical Devices (Eudamed) is also planned to improve data quality, interlinkage and transparency. The medical devices regulation introduces changes including stricter rules for reprocessing of single-use devices. The main changes are:

Quality, safety and reliability of medical devices: The new rules expand the definition of a medical device and will cover certain, previously unregulated aesthetic products (e.g. coloured contact lenses that do not correct vision). Tighter controls will be imposed on clinical trials together with the introduction of special notified bodies for high-risk devices such as implants. A new system for risk classification in line with international guidelines will apply to in vitro diagnostic medical devices.

Transparency of information for consumers: The new regulations will ensure information accessibility. For instance, patients will receive an implant card with all the essential information, and a unique device identifier will be mandatory for every product.

Vigilance and market surveillance: EU countries will coordinate more closely in the field of market surveillance with enhanced post-market oversight powers for notified bodies including unannounced audits. Manufacturers will be obliged to collect data about the performance of any product from its entry to the market with a requirement to monitor and act promptly if emergencies arise.

Access to the Eudamed repository (currently only for competent authorities and the European Commission) will expand to include market participants including notified bodies, Medical Device Coordination Groups, economic operators (manufacturers, authorized representatives, etc), non-European market regulators, and public entities (medical institutions, press organizations, etc).
Data will include information as to where in Europe devices have been distributed and which parties are responsible for the products in addition to:

• Unique device identification (UDI) data
• Single registration numbers for all economic operators
• Accreditation and designation data for notified bodies
• More vigilance and post-market surveillance data
• Notified body conformity assessment applications
• Safety and clinical performance summaries for medical devices and IVDs
Apart from new classification rules and stricter requirements for re-using single use devices, specific rules for software as a medical device are introduced, accounting for the significant developments in this area in the past 20 years. In addition, a pre-market scrutiny procedure is introduced for certain types of high-risk devices.

EC Press Release
EP Press Release

Access regulations in your language:

Medical Devices
In Vitro Diagnostics
MDR (Eur-Lex)

EIP Active Healthy Ageing

The EU EYE has been officially accepted in the European Innovation Partnership on Active and Healthy Ageing (EIP-AHA) of the European Commission. This is a recognition of the efforts and the added value that the EU EYE brings to this collaborative network in creating a forum for integration of research priorities, policies and strategies in eye health. The EU EYE will explore potential synergy actions with members of EIP AHA who have similar interests and activities.

The European Innovation Partnership on Active and Healthy Ageing EIP-AHA brings together key stakeholders in public health from universities, research groups, public authorities, health care providers, industry and non-governmental organizations representing citizens and patients. The following Directorate Generals are currently interested in the work of the EIP-AHA:
DG Connect (digital development of EU); DG SANCO (the public health unit); DG Research & Innovation; DG REGIO (managing the structural funds); and DG EMPL (DG Employment Social Affairs & Inclusion). The EIP-AHA has six thematic Action Groups:

• Action Group A1: Adherence to treatment
• Action Group A2: Falls prevention
• Action Group A3: Functional decline and frailty
• Action Group B3: Integrated care
• Action Group C2: Independent living solutions
• Action Group D4: Age friendly environments

Access the Commitment of the EU EYE to the B3 Action Group on Integrated Care of EIPAHA
/ (submitted and validated in December 2017).

	Commitment of the EU EYE to the EIP AHA The EU EYE infographic on the commitment of the organisation to the B3 Action Group on Integrated Care was presented in the 6th Conference of Partners of the EIP AHA on 27-28 February 2018. View here
	Billion Euro Burden on Europe An infographic giving an overview on the multifaceted impact of vision impairment on the patients and the economy. It also explains why research is necessary for determining cost-effective interventions. View here
	Preventing Sight Loss in Ageing Population | European Parliament A keynote presentation at the European Parliament by the EUEYE on the role of screening and early diagnosis in identifying eye diseases as comorbidities of non-communicable diseases. View here

European Disability Strategy 2010-2020

Disability is a rights issue and not a matter of discretion. The UN Convention on the Rights of People with Disabilities, obliges its parties to produce an Implementation Strategy. The European Union adopted the European Disability Strategy 2010-2020 in 2010, to fulfill its obligation to UN and to complement national efforts with a European-wide framework. The main aim of the Strategy is to empower persons with disabilities so that they can fully enjoy their rights and to participate in society and the economy on an equal basis with others.

The Strategy has identified eight main areas for action at EU level:

A number of actions have already been carried out in terms of improving access to buildings, equal opportunities in work environment, etc.
Access the European Disability Strategy in your language

Joining the call on employment of people with chronic diseases The EU EYE has endorsed the Joint Statement on “Improving the employment of people with chronic diseases in Europe” prepared by the European Chronic Disease Alliance, which is leading the Thematic Network on the EU Health Policy Platform. View here

European Professional Card and the Alert Mechanism

The Directive 2013/55/EU amending Directive 2005/36/EC on the recognition of professional qualifications and Regulation (EU) No 1024/2012 on administrative cooperation through the Internal Market Information System (IMI) was implemented in January 2016. The new directive aims to facilitate and enhance the mobility of professionals across the EU and to address local staff shortages. It introduces the European Professional Card (EPC), an electronic certificate one can use to have his/her professional qualifications recognised in another EU country. The EPC is currently available for five professions (general care nurses, physiotherapists, pharmacists, real estate agents and mountain guides). It might be extended to other professions in the future.

The EPC does not replace the ‘traditional’ recognition procedures under the Professional Qualifications Directive.

An alert mechanism integrated within the IMI ensures that EU patients and consumers are adequately protected. The Competent Authorities of EU countries are required to warn each other about professionals who:
• have been prohibited or restricted from practicing the profession in one country
• have used falsified diplomas for their application for the recognition of their qualification.

eHealth

The eHealth Action Plan 2012-2020 is a roadmap to deliver smarter, safer and patient-centred health services by empowering patients and healthcare workers, linking up devices and technologies, and investing in research towards the personalised medicine of the future. The Action Plan includes a special focus on mobile health (mHealth). The eHealth Action Plan is a communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions.

The eHealth is part of the Digital Single Market Strategy for Europe which was adopted by the European Commission. The strategy aims to boost growth and jobs in the EU through the digitalisation of Europe and it includes efforts on interoperability and standards in telemedicine and ehealth for the benefit of patients, health professionals, health systems and industry.

A voluntary Network of national authorities responsible for eHealth has also been set up according to the Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare. The eHealth Network will draw up guidelines in the area of eHealth. It aims to enhance interoperability between electronic health systems and continuity of care and to ensure access to safe and quality healthcare.

Additional information:
ehealth/network_en
Cross Border Directive.pdf
Digital-single-market

Patient safety and Medical Training

The capacity of health systems to deliver health services and meet the changing demands of care depends on the availability of a workforce with the right skills and flexibility. EU-wide activities in health workforce planning and forecasting support EU countries in building national capacities. Our members support high levels of specialist training as part of our commitment to patient safety and quality care. We invest consistently in continuous professional development so that the ophthalmology services of our respective national health systems are better equipped to respond to the major challenges that the EU is facing with the prevalence of eye diseases in an ageing population.

The ongoing commitment of our members to education, excellence and innovation is demonstrated by:
– evaluating knowledge and expertise through certification programmes in each subspecialty;
– providing funding for training, identify training sites and facilitating access to fellowship and residents’ programmes;
– creating innovative tools and resources including online educational portals that transfer new knowledge into clinical practice.
– launching international journals to promote the study and learning of the science and practice of all matters related to the health and management of the eye as an organ and as part of the patient as a whole.

Joining the call on medical training for patient safety The EU EYE has endorsed the Joint Statement of the Thematic network on medical training and professional development for patient safety led by the European Society of Radiology. View here

WHO World Report on Vision

EU EYE calls for fairer assessment of cost-effectiveness and a balance in metrics regarding the disease impact on the quality of life. Read more on the EU EYE’s position regarding the WHO Report

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