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European Society of Radiology

ESR

The European Society of Radiology is the European body representing the radiology profession with over 142,000 individual members worldwide and acts as the umbrella organisation of all national radiological societies in Europe as well as Europe’s subspecialty organisations in the field of radiology.

Lobbying Activity

Response to EU’s next long-term budget (MFF) – EU funding for competitiveness

12 Nov 2025

The European Society of Radiology (ESR) welcomes the European Commissions proposal for the next Multiannual Financial Framework (MFF) and the ambition to double the Horizon Europe budget under the next Horizon Europe programme for the period 2028-2034. ESR fully supports the ECs recognition of research and innovation as central pillars to strengthen Europes competitiveness, resilience and societal wellbeing. ESR however notes with concern that, in the proposal, health will be grouped with agriculture and the bioeconomy and calls upon the EC to create a stand-alone budget for health research to advance the European Health Union. Medical Imaging is a key driver of European health research in all disease areas, leading innovation in diagnostics, therapy guidance, and population health in partnership with other biomedical disciplines. Continued funding of imaging research is crucial to achieve Europes ambition to enable data-driven precision medicine and outcome-based healthcare. Medical imaging is at the forefront of digital transformation of healthcare with AI tools increasingly deployed to enhance image interpretation, support clinical decision-making and workflow management, and enable more personalised and effective patient care. ESR calls upon the EU institutions to Install a stand-alone ringfenced budget for health research to advance the European Health Union with high-impact, equitable health research and to avoid depriorisation. Ensure that public health needs define the priorities of the Next Framework Programme, enabling research that directly improves citizens lives, strengthens health systems and supports Europes competitiveness. Continue implementation of Europes Beating Cancer Plan and renew the Cancer Mission, enshrining cancer as a policy and budget priority in the future MFF. The Cancer Image Europe infrastructure implementing the European Cancer Imaging Initiative has shown the power of high-quality big data to accelerate cancer research, diagnosis and innovation. Also, funding for the development and deployment of AI for cancer screening (breast, lung, prostate, colorectal) to improve early detection, reduce screening cost and address inequalities in access, is key to improve Europes population health and competitiveness. Ensure funding for cardiovascular health research as part of the European Cardiovascular Health Plan Imaging is key at every stage of cardiovascular disease care: prevention, screening, diagnosis, treatment, and follow-up. AI in cardiovascular imaging holds a transformative potential, reshaping how heart diseases are diagnosed, treated, and managed. Cancer Image Europe has provided a blueprint for a federated infrastructure for high-quality images and related clinical data and should be leveraged for cardiovascular health. ESR stands ready to work with the EU and other stakeholders to engage in cutting-edge cardiovascular health research to contribute to a coherent, inclusive, and innovation-driven European response to the cardiovascular disease burden. Enhance AI research in health To fully harness AIs potential in healthcare at large and medical imaging and to strengthen Europes competitiveness in the field, continued funding of AI innovation and uptake in the future Horizon Europe programme is crucial. Support large-scale deployment of trustworthy AI solutions in healthcare to translate Europes strong AI research base into real clinical impact with dedicated funding for better patient outcomes and system efficiency. The ESR and Europes imaging community stand ready to contribute their expertise to a successful Horizon Europe framework that advances health innovation across Europe, reduces health inequalities, and ensures a balanced and sustainable approach between boosting competitiveness and enhancing health and wellbeing for Europes citizens. As a member of ECO and the BioMed Alliance, ESR fully supports the statements of these organisations.
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Response to Digital package – digital omnibus

14 Oct 2025

The European Society of Radiology (ESR) welcomes the Digital Omnibus proposal, the initiative of the Commission to simplify obligations in the Artificial Intelligence Act, and it is eager to contribute to the call for feedback on the proposal. However, the ESR would also like to stress the importance of ensuring that sufficient standards are in place to safeguard safety in the medical profession, maintain a proper balance of responsibilities, and uphold the highest level of patient care. The Digital Omnibus shall not result in loosening obligations and lack of standards, but rather in a simplification and legal certainty. The ESR strongly advises that the below-mentioned points are taken into account in the proposal. 1. Integration of post-market surveillance (PMS) obligations between AI Act and MDR The EU Digital Omnibus should promote technical and procedural alignment between AI Act Article 72 and MDR post-market surveillance requirements. In particular, it should enable real-world monitoring through clinical registries and PACS-linked infrastructure. This requires allowing data flows from hospital systems to feed into EU-level monitoring frameworks (e.g., via the EHDS) without duplicative reporting burdens. 2. Compliance obligations for General-Purpose AI (GPAI) in medical contexts Clear downstream compliance obligations are needed for GPAI providers when their models are integrated into medical devices or clinical workflows. The Digital Omnibus should define the allocation of responsibilities between GPAI providers and medical-device manufacturers, including conformity assessments, technical documentation, and communication of model updates that may impact clinical safety or diagnostic performance. Special attention should be paid to post-market surveillance of GPAI models, in view of their rapid evolution. 3. Alignment between AI Act and MDR quality and conformity requirements For medical AI, dual compliance under the AI Act (as high-risk AI) and the MDR (as medical device) currently leads to overlapping QMS requirements, documentation, and post-market monitoring. Harmonisation is needed. The ESR recommends harmonised QMS documentation and joint conformity processes, as outlined in our AI Act policy paper. 4. Clarifying deployer obligations and shared responsibilities Hospitals and radiology departments act as deployers of AI systems but currently lack clear, proportionate guidance on obligations such as logging, risk monitoring, and incident reporting. The Digital Omnibus should define practical templates and interoperable reporting channels. This would prevent duplication across the AI Act, MDR, and GDPR, and avoid the need for parallel infrastructures. 5. Transparency implementation Transparency obligations under AI Act Articles 13 and 14 should be operationalised through model cards and sector-specific guidance, rather than new documentation requirements. Simplification can be achieved by standardising documentation formats across sectors, building on work from initiatives such as the ESR AI Working Group and the Metrics Reloaded consensus on performance reporting. 6. AI literacy AI literacy should be embedded into existing professional training frameworks. There is no need to create new, standalone certification schemes. In summary, the ESR supports the goals of the Digital Omnibus and calls for coherent, medically appropriate implementation that ensures clarity of responsibilities, avoids duplication, and maintains the highest standards of patient safety and care.
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Response to EU cardiovascular health plan

12 Sept 2025

The European Society of Radiology (ESR) welcomes the EU plan to reduce the burden of cardiovascular diseases (CVDs) focused on prevention, early detection and screening, as well as management, care and rehabilitation. The EU Cardiovascular Health Plan (CVHP) offers a key opportunity to not only address CVD but also advance broader public health, equity, and economic goals. Imaging is key at every stage of CVD care: prevention, screening, diagnosis, treatment, and follow-up. It enables precision diagnosis and risk stratification. Non-invasive cardiovascular imaging (CT, MRI, nuclear imaging) is essential for (early) diagnosis, treatment selection and prognosis prediction of CVDs. In CVD prevention efforts, imaging can more effectively differentiate between those at high and low risk of CVD than traditional risk factors, as shown in large-scale imaging studies. Implementing calcium scoring in specific risk stratification groups can enhance prevention programs by identifying individuals with hidden coronary atherosclerosis. The impact of calcium score screening is presently under investigation in the radiologist-led ROBINSCA study. Additionally, coronary calcium can be evaluated using lung cancer screening CT scans, to increase the cost-effectiveness of chest CT screening programs. Also, chest CT scans performed as part of routine clinical practice allow opportunistic coronary calcium screening to identify individuals with hitherto unknown elevated cardiovascular risk, providing the opportunity for early detection and treatment at minimal effort and cost. The ESR calls upon the EU to support the development of evidence-based guidelines for CVD screening and treatment. This includes integrating imaging-based screening and precision medicine strategies into future healthcare plans. It also calls for support to Member States in developing pilot programs and rollout plans. Priority should be given to initiatives to implement opportunistic screening for coronary calcium in either lung cancer screening or clinical setting. Cardiac CT, MRI and nuclear imaging have become indispensable components of cardiovascular research methodology and clinical care pathways. Their implementation in clinical studies offers Precise phenotyping of CV pathologies Objective therapy response assessment Non-invasive longitudinal monitoring of disease progression Deeper insights into pathophysiological processes Quantitative endpoints for interventional trials ESR can contribute to a digital CVH policy environment through its longstanding experience in medical AI and guidance for digital healthcare transformation. Radiology is at the forefront of AI development. AI provides promising solutions across various stages of the cardiac imaging process, including patient and test selection, image acquisition, reconstruction, interpretation, and extending to prognosis and reporting. Combining different data sources including imaging, ECG, lab and clinical data allows development of a digital twin which can help to identify patient trajectories and assist in personalized management at every step of the CVD continuum. The ESR calls upon the EU to align the EU CVHP with the EHDS, the AI Act and Apply AI Strategy and to build on the expertise gained during implementation of the Europes Beating Cancer Plan, including the European Cancer Imaging Initiative as one of its flagships implemented by radiologists (Cancer Image Europe/EUCAIM), and to launch a related initiative for the cardiovascular field. Cancer Image Europe, the federated infrastructure for cancer images and related clinical data, provides a blueprint for cardiovascular imaging data integration, AI development and benchmarking, and research. The ESR stands ready to work with the EU and other stakeholders to design and implement the EU CVHP as a coherent, inclusive, and innovation-driven European response to CVD to the benefit of Europes citizens.
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Response to Apply AI Strategy

4 Jun 2025

The European Society of Radiology (ESR) welcomes the European Commissions strategic focus on the development and uptake of Artificial Intelligence (AI) through the Apply AI Strategy. As a transformative enabler in healthcare, AI holds immense potential to advance diagnostics and personalised treatments, improve patient outcomes, and strengthen Europe's technological and industrial capacity in the life sciences. Radiology is at the forefront of this transformation, with AI tools increasingly deployed to enhance image interpretation, support clinical decision-making, and enable more personalised and effective patient care. To fully harness AIs potential in medical imaging, the ESR highlights the following key priorities aligned with the strategys goals: 1. Investment in AI innovation and uptake Sustained funding for AI in medical imaging: Continued support under Horizon Europe, EIC and future programmes is critical for advancing AI-based imaging tools, including integrated diagnostics and clinical decision support systems. Targeted investment in population-based screening: Funding should prioritise the development and deployment of AI for cancer screening (breast, lung, colorectal) to improve early detection, reduce screening cost and address inequalities in access across Member States. Support for testing and experimentation: Establish and expand testing infrastructures and regulatory sandboxes for AI in imaging to ensure patient safety and accelerate clinical adoption. 2. Infrastructure, standards, and data Robust digital infrastructure and data access: AI in imaging relies on access to high-quality, representative datasets. Investments in secure, interoperable infrastructure that enables federated learning and cross-border collaboration are essential (e.g. the European Cancer Imaging initiative implemented by the EUCAIM project). Standardisation and interoperability: Establishing common technical standards for imaging equipment, data annotation, and AI model integration is crucial to ensure usability, safety, and trust. 3. Skills, workforce, and equity Education and digital upskilling: Investment in digital and AI literacy programmes for radiologists and imaging professionals is needed to ensure responsible deployment and integration into clinical workflows. Workforce resilience and inclusion: AI should support the radiology workforce, not replace it. Strategies must promote interdisciplinary collaboration and attract talent to address shortages in the healthcare sector. Equitable access and affordability: EU actions must ensure AI-enabled imaging technologies are accessible and affordable across all Member States, including underserved regions. 4. Governance, ethics, and trust Agile and transparent regulatory pathways: Implementation of the AI Act and other relevant frameworks (General Data Protection Regulation, Medical Devices Regulation, Health Technology Assessment Regulation, European Health Data Space Regulation etc.) must ensure legal clarity for AI in imaging, with proportionate oversight mechanisms to support innovation while protecting patients. Inclusive implementation with clinical expertise: Strong stakeholder engagement and capacity building are vital to ensure meaningful adoption. Clinicians and domain experts should be actively engaged in the forthcoming AI Research Council, alongside the AI Scientific Panel and AI Stakeholder Forum. Their systematic involvement should be integrated into the operational workflow of the Apply AI Strategys implementation, ensuring decisions are grounded in real-world needs and ethical, clinically relevant innovation. Post-market monitoring and liability: Ongoing monitoring of AI performance in real-world settings and clarification of liability rules and AI providers responsibilities will be key to ensuring safe deployment and building public trust. The ESR stands ready to contribute its clinical and technical expertise to the implementation of the App
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Response to EU Life sciences strategy

17 Apr 2025

The European Society of Radiology (ESR) applauds the initiative to create a Strategy for European Life Sciences aiming to advance life sciences-based innovation across Europe by addressing key barriers and to re-install Europes competitiveness and status as global leader. It is important to ensure that the EU Life Science Strategy aligns with the European Health Union and the next EU Framework Programme for Research and Innovation and that it supports a harmonised and smooth implementation of other relevant legislation, including the AI Act and the EHDS to foster innovation in life sciences. For medical imaging, several critical needs must be addressed to ensure its effective integration and advancement within this strategy, in order to bring innovations to the market to further improve prevention, diagnosis, treatment decision making, and monitoring of disease: Investment in advanced imaging technologies: Continuous funding for research and innovation actions and public-private partnerships in cutting-edge imaging technologies and integrated diagnostics fully leveraging the potential of AI is essential Investment in AI based image screening (bowel, breast, lung cancer) to improve access to screening and manage costs. Standardisation and interoperability: Further investment in establishing common standards for medical imaging equipment and software to ensure compatibility and interoperability across different healthcare systems. Cross-border collaboration and digital infrastructure: Robust digital infrastructure in Member States that supports federated learning and cross-border data sharing is key to training and validating AI in imaging and multimodal AI solutions on real-world clinical data. Education and training: Enhancing training programs for health professionals including upskilling programs, AI and digital literacy and re-certification trainings to keep pace with the latest imaging advancements and incentives to attract more people into the health professions and to keep the health workforce in Europe. Streamlined regulatory pathways: A collaborative effort with relevant stakeholders is needed to simplify regulatory procedures, offering support to innovators on the processes and to ensure agile, transparent pathways for innovation while upholding patient safety, data security and privacy. Equity, accessibility and affordability: Making advanced imaging technologies more accessible and affordable to healthcare providers and patients across the EU.
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Response to EU rules on medical devices and in vitro diagnostics - targeted evaluation

21 Mar 2025

The European Society of Radiology (ESR) welcomes the opportunity to submit a call for evidence on the evaluation of the Medical Devices Regulation. The evidence that follows is based on the experience prevalent in interventional radiologist units, which have been more affected by the shortcomings of the MDR. In particular, it is contended that, as it stands, the MDR is unintentionally pushing long-established, clinically safe, and essential devices off the EU market. Under the MDR, manufacturers are required to generate extensive new documentation, repeat testing for each product variation, and undergo costly, time-intensive re-certification processes every five years. In interventional radiology, coils, catheters, and guidewires that have proven safety and well-established clinical value, are impacted by the MDR due to their many permutations of size, shape, and configuration. In fact, even a minor adjustment triggers the need for full re-certification. Coils, for instance, come in a wide range of diameters, shapes (round, spherical, complex), and lengths. Guidewires present similar complexity, with combinations across length, diameter, tip configuration, stiffness, and additional features. The same applies to catheters, which are required in over 20 different shapes, multiple lengths, and diameters. This results in a massive number of possible combinations, yet the regulation requires each individual variant to undergo separate certification, even if it has been safely used in clinical practice for decades. This situation has several critical consequences. First, the volume of documentation now required (often up to 1,000 pages per product compared to around 50 under the previous regulatory system), coupled with a mandatory five-year re-certification cycle has introduced a level of bureaucracy and financial strain that is not proportionate to the risks of long-established, low-risk devices. Additionally, when clinical demand returns for a previously certified product that had been withdrawn from the market due to low demand, reintroducing can take at least two years due to a lack of fast-track procedures. The above places a disproportionate burden on manufacturers, particularly SMEs, forcing them to reduce product portfolios based not on clinical relevance but on regulatory cost. Unlike the pharmaceutical sector, the medical devices market typically operates with smaller profit margins - which makes the regulatory demands of the MDR have a much greater impact on manufacturers' abilities. Furthermore, limited capacity in notified bodies and long re-certification timelines further hinder the availability of existing products and delay innovation. As a result, clinically important devices especially for paediatrics, rare conditions, and emergency interventions are disappearing from hospitals. The current system disincentivises the maintenance of broad product portfolios, delays the return of needed devices to market, and deprioritises patient needs in favour of procedural compliance. To address these shortcomings, the MDR should incorporate a simplified and accelerated pathway for re-certifying devices that have a long-standing record of safety and clinical effectiveness. This would include a more rational approach to product families, so that minor technical variations do not trigger full, separate certification procedures. Additionally, a specific mechanism should be introduced to allow for the rapid re-approval of previously certified products that are needed again in clinical practice. Addressing the current bottlenecks also requires investment in the capacity and expertise of notified bodies, ensuring that SMEs have fair and timely access to the regulatory system. Without these changes, the MDR risks undermining its core objective ensuring access to safe, effective medical devices by making essential, proven products unnecessarily difficult or costly to maintain on the EU market.
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Response to Implementing regulation for electronic instructions for use for medical devices

20 Mar 2025

The European Society of Radiology welcomes these proposed amendments to the existing regulations. Providing Electronic Instructions for Use (eIFU) to professional users improves overall accessibility, and removes the need to store and access physical copies in hospital departments, with all the associated risks (such as loss or damage of the paper IFU, and slow speed of manual look-up due to the size of paper IFU). The environmental impact of producing and distributing paper documents can be reduced, and communication and integration of updates to IFU can potentially be a smoother process. Whilst we recognise that there are likely to be overall improvements to accessibility by moving from hard copy to electronic instructions, we would emphasise the continued need to ensure risk assessment specific to the diverse circumstances in which users operate medical devices, as per the original Commission Implementing Regulation (EU) 2021/2226. We also support the continuation of requirements to provide paper instructions to patients for implantable medical devices. Finally, we would encourage and support the implementation of eIFUs by most or all manufacturers as soon as possible, and ideally much earlier than the current deadline of 2028.
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Response to Establishment of the scientific panel of independent experts under the AI Act – implementing regulation

15 Nov 2024

We welcome the chance to contribute to this open consultation on the Draft Regulation for establishing the AI Scientific Panel of Experts. As representatives of the healthcare community, particularly in radiology, we see this as a crucial step toward effective governance and safe integration of AI technologies into specialized domains such as medical imaging. Article 3: The draft regulation could benefit from clarity regarding the selection process for the call of expression of interest. We recommend ensuring transparency and consistency in this process, particularly in eligibility requirements and evaluation procedures. While national representation is valuable, we suggest placing equal emphasis on sector-specific expertise. In healthcare, and radiology specifically, distinct challenges and applications require specialized knowledge, best addressed by professionals with deep expertise. We also recommend elaborating on the role of the reserve listits strategic purpose, intended use, and how those on it may eventually be engaged in the panels work. Article 7: The tasks of the AI Scientific Panel as defined seem largely reactive, responding to requests rather than contributing proactively. It could be valuable to explore a more permanent advisory role to ensure continuous integration of scientific expertise, particularly for AI applications in healthcare. Further clarification on the process of requesting recommendations or opinions would provide insight into how sector-specific expertise will be organized, which may benefit from thematic working groups. Article 12: While we welcome the commitment to post-establishment transparency, it is equally important to ensure transparency in the establishment process itself. Currently, there is no clarity on how the open call for expression of interest will be organized or what selection criteria will be applied. Healthcare professional organizations like ESR possess the networks and knowledge necessary to effectively reach medical professionals. Understanding how the AI Office plans to conduct the call is essential for us to provide constructive feedback to ensure the panel includes diverse expertise, particularly in healthcare and radiology. We believe these amendments will strengthen the regulation, enhancing its effectiveness in ensuring a competent, well-composed AI Scientific Panel. We welcome the chance to provide feedback and hope similar stakeholder engagement remains core to the AI Act's governance. References Brady AP, Neri E. Artificial Intelligence in Radiology-Ethical Considerations. Diagnostics (Basel). 2020 Apr 17;10(4):231. doi: 10.3390/diagnostics10040231. PMID: 32316503; PMCID: PMC7235856. European Society of Radiology (ESR). Guiding AI in Radiology: ESR's Recommendations for Effective Implementation of the European AI Act. Insights Imaging (under revision). European Society of Radiology (ESR). What the radiologist should know about artificial intelligence - an ESR white paper. Insights Imaging. 2019 Apr 4;10(1):44. doi: 10.1186/s13244-019-0738-2. PMID: 30949865; PMCID: PMC6449411. European Society of Radiology (ESR). Current practical experience with artificial intelligence in clinical radiology: a survey of the European Society of Radiology. Insights Imaging. 2022 Jun 21;13(1):107. doi: 10.1186/s13244-022-01247-y. PMID: 35727355; PMCID: PMC9213582. European Society of Radiology (ESR). Impact of artificial intelligence on radiology: a EuroAIM survey among members of the European Society of Radiology. Insights Imaging. 2019 Oct 31;10(1):105. doi: 10.1186/s13244-019-0798-3. PMID: 31673823; PMCID: PMC6823335. Zanardo M, Visser JJ, Colarieti A, Cuocolo R, Klontzas ME, Pinto Dos Santos D, Sardanelli F; European Society of Radiology (ESR). Impact of AI on radiology: a EuroAIM/EuSoMII 2024 survey among members of the European Society of Radiology. Insights Imaging. 2024 Oct;15(1):240. doi: 10.1186/s13244-024-01801-w. PMID: 39373853; PMCID: PMC11458846.
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Response to A European Health Data Space

28 Jul 2022

The European Society of Radiology (ESR) welcomes the European Commission’s proposal for the European Health Data Space (EHDS), a crucial way towards ensuring patient-centered healthcare, by using patient data to continuously improve patient care and health outcomes. ESR fully embraces the concept of the EHDS and has worked on various elements to analyse existing hurdles and to facilitate sharing of imaging data in the future. ESR is a member of the ehealth Stakeholder Group of the European Commission and researchers and clinicians from the ESR membership are coordinating major European research projects to advance sharing of imaging data within the framework of the AI4Health Cluster of Horizon 2020. Also, the ESR is contributing strongly to the implementation of the European Cancer Imaging Initiative of the Europe’s Beating Cancer Plan and has supported a strong consortium to address the recent Digital Europe call on federated European infrastructure for cancer images data. Hence, ESR is eager to engage with the EHDS and to support implementation. However, although digital transformation of healthcare is a major priority in European health policy, hurdles remain impeding the adoption of digital health technology in the healthcare setting. In ESR’s view, a number of aspects of the proposed EHDS legislation require further clarification and explanation, detailed in the attached document.
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Response to Cancer Screening Recommendation

22 Feb 2022

The European Society of Radiology (ESR) welcomes the update of the Council recommendations on cancer screening and that this process considers extending targeted cancer screening to other cancer types. The ESR particularly suggests including lung cancer and prostate cancer in the updated recommendations based on the recent compelling scientific evidence. The ESR also highlights the importance to foster development, support clinical testing and advance uptake of promising new technologies to improve screening methods and early detection of cancer, including in particular artificial intelligence solutions. This will contribute to improving equitable access to screening programmes across the EU. Adequate training of medical workforce in using new screening methods and AI-based solution needs to be ensured. Please refer to the attached statement for details and references.
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Response to Proposal for a Regulation on a Union framework addressing public health emergencies (EMA)

7 Jan 2021

The European Society of Radiology (ESR) welcomes the European Commission’s proposal to determine a clear framework for the deployment of the activities of the European Medicines Agency (EMA) to monitor and mitigate potential and actual shortages of medicinal products and medical devices. The ESR agrees that the COVID19 pandemic has put a strain on the medical devices industry which had to adapt to a sudden and uncoordinated increase in demand at European Union level. Therefore, it is important for the EMA to have a reinforced role in crisis preparedness and management for medicinal products and medical devices. Governments bear the responsibility to ensure healthcare professionals have enough Personal Protective Equipment (PPE) and other resources necessary, and the ESR supports the suggested measures to help Member States be better prepared for a sudden increase in demand. Moreover, solidarity and harmonisation at EU level are essential for efficient exchanges of information and to avoid export restrictions within the European Union or excessive and uncoordinated stockpiling. The European Society of Radiology further concurs with the proposal for increased coordination at Union level to identify, as cross-border health threat occurs, areas and hospitals in need of medical technologies throughout Europe. The ESR welcomes the establishment of a permanent structure within the agency for the functioning of expert panels and their additional responsibility to provide scientific advice relevant for crisis preparedness and management. However, members of the Medical Devices Steering Group should be accompanied by a diversity of experts to be invited to attend the meetings. The ESR further suggests that the EMA includes medical professionals when drafting the list of authorized representatives for the provision of information on medical devices. As professionals working with patients to diagnose or to identify the right level of patient care, it is paramount that imaging professionals’ input be taken into consideration in medical device expert panels and in any expert panel for technical assessment and advice on medical devices. The European Society of Radiology warmly supports the European Commission proposal to reinforce the role of the European Medicines Agency. However, the ESR believes that the collection of data on shortages, through national and EU mechanisms, should involve hospitals and multidisciplinary teams of healthcare providers, so that any outbreak can be timely and adequately addressed. Besides, when liaising with international organisations to mitigate potential or actual shortages of medical devices, the European Commission would benefit greatly from the input of pan-European medical societies that provide continuing medical education to health professionals and promote best clinical practices.
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Response to Proposal for a Regulation establishing a European Centre for Disease Prevention and Control (ECDC)

6 Jan 2021

The European Society of Radiology (ESR) warmly welcomes the European Commission’s proposal to reinforce the mandate of the European Centre for Disease Prevention and Control (ECDC). The COVID19 epidemic has exacerbated the need for establishing adequate surveillance, preparedness, early warning and response measures for future pandemics. The ESR agrees with the European Commission’s ambition to reinforce the ECDC’s capacities and build key specific competences to monitor and assess health systems’ abilities. Indeed, health systems should possess the abilities to diagnose, prevent and treat specific communicable disease. In the case of a pandemic, medical imaging departments should be geared towards a temporary emergency situation that calls for tightened safety measures and adjusted working procedures. Furthermore, the number of staff with direct patient contact must be minimised and non-urgent imaging procedures postponed. As the umbrella organisation of European radiological societies, the European Society of Radiology believes that the needs and conditions of all healthcare professionals should be considered when monitoring and assessing health systems’ capabilities to face cross-border health threats. Moreover, the European Society of Radiology supports the mobilisation and deployment of the EU Health Task Force to assist the response in Member States. The ESR believes that to provide adequate support to governments, multidisciplinary teams of health professionals should be involved in the definition of the EU Health Task Force and in the establishment of its procedures. Indeed, imaging professionals have had essential roles in the response to pandemics, for diagnoses or the determination of the level of patient care, and can provide valuable input in framing the EU Health Task Force. The ESR also calls attention to the benefits of involving medical imaging professionals in the identification of population groups at risks and in need of targeted prevention. During pandemics, radiology departments implement guidelines to protect healthcare workers and patients while preserving critical radiological operations, all while making the decision to postpone some operations deemed non-critical. Therefore, the imaging workforce holds first-hand experience of identifying population groups at risk that require specific attention. The European Society of Radiology further welcomes the European Commission’s recognition of the importance of research in the establishment of an adequate preparedness plan and response to health pandemics. The ESR wishes to emphasise that multidisciplinary experts should be consulted in the definition of research priorities, for a comprehensive overview of the European Union’s research needs to address global health pandemics. The ESR welcomes the European Union’s initiative on reinforcing the mandate of the ECDC. We call on the EU institutions and Member States to collaborate, across borders and sectors, and include the input of multidisciplinary teams of health experts to address future health challenges.
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Response to Proposal for a Regulation on serious cross-border threats to health

6 Jan 2021

The European Society of Radiology welcomes the European Commission’s proposal for a stronger and more comprehensive legal framework to react rapidly and trigger the implementation of preparedness and response measures to cross-border health threats. Medical imaging maintains an essential role in the diagnostic process of COVID19. Chest imaging is a complementary tool to determine a correct diagnosis and the extent of the disease in a patient. Therefore, it has been paramount in the care pathway of COVID19 patients. The recent pandemic is not the only one where imaging professionals have proved essential. Many lives are saved by tuberculosis (TB) diagnosis done through chest radiography, counteracting the TB epidemic that killed 1.4 million people in 2019. This is why the European Society of Radiology believes that imaging professionals should have a say and should be consulted on the establishment of the pandemic preparedness plan as well as its requirements at the national level. Being on the forefront of the fight against various pandemics, radiologists can provide valuable input to amendments made to preparedness capacities. Likewise, the expertise of imaging professionals and of medical societies is beneficial in the determination of rules on the provision of training for healthcare and the public health workforce. Indeed, the role of medical societies is to provide medical education to the workforce and promote best clinical practices and patient safety. The ESR urges the European Commission to recognise the importance of involving medical professionals and medical societies from multiple disciplines in framing the amendments put forward in the proposal regarding the preparedness plan and training. Their input ensures trusted, real-world evidence and scientifically sound input to prepare efficiently for future cross-border health threats. Furthermore, the ESR supports the European Commission’s acknowledgement of the role of research and its ambition to establish a network of EU reference laboratories for public health. However, we believe that this network should ensure the inclusion of imaging research laboratories. Provided the role of medical imaging in the fight against pandemics, imaging research should not be ignored when the time comes to designate and fund EU reference laboratories for public health. The European Society of Radiology welcomes this proposal for the European Union to prepare and respond to health crises through a preparedness plan, adequate training of medical professionals and a network of reference laboratories. However, the ESR calls on the European Commission to recognise the role of medical imaging in the fight against pandemics and to include multidisciplinary medical professionals when framing the amendments in the proposal for a regulation on serious cross-border threats to health.
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Meeting with Stella Kyriakides (Commissioner) and

7 Oct 2020 · Discussion on Europe's Beating Cancer Plan and the need for early detection and diagnosis.

Response to Europe’s Beating Cancer Plan

2 Mar 2020

The European Society of Radiology welcomes the roadmap on the ‘Europe’s Beating Cancer Plan’ that has identified areas of action tackling all stages of the disease. The European Commission’s openness to stakeholder input is very reflective of the disease’s complex nature which can be addressed solely by multistakeholder collaboration and a holistic approach that goes beyond the healthcare field. The ESR supports the roadmap’s focus on prevention to reduce cancer incidence through increased action on environmental and lifestyle factors as well as medical interventions. However, the basis for a coordinated and strengthened approach on early detection and diagnosis laid out in the roadmap is similarly crucial to reduce mortality. As a result, the EU cancer plan should enhance implementation of existing screening programmes (breast, cervical and colorectal), while considering the latest evidence on new ones (lung, gastric and prostate) for equal access to screening across Europe. The EU cancer plan should drive a discussion on updating the 2003 Council Recommendation on Cancer Screening to take stock of the latest evidence and innovation. Available evidence supports the implementation of targeted pilot lung cancer screening programmes, and more info can be found on this matter in the attached ESR-ERS statement paper on lung cancer screening. Furthermore, the EU cancer plan should support Member States in implementing effective screening programmes by institutionalising a framework that allows to monitor progress in screening through the exchange of data across borders and by developing national action plans. It is key for the cancer plan to implement an integrated approach to ensure and improve access to medical technologies in the fight against the disease. Member state coordination is to be strengthened to address questions on access and reimbursement of innovative technologies. Additionally, the plan should be closely aligned with the EU Cancer Mission and offer pathways to incentivise research on innovative medical technologies and AI-driven solutions which could enhance access to treatments and reduce time to diagnosis. Furthermore, access to medical technologies should be regularly benchmarked and debated at EU level through an active dialogue with industry, the medical profession, patients, insurance authorities and researchers. The digitisation of cancer care should be a cross-cutting and horizontal priority throughout the EU cancer plan with the aim of supporting member states in the digital transformation of healthcare. The plan should tie in with existing EU initiatives to create a European Health Data Space to design and implement a federated data infrastructure that allows the exchange of health data for research, diagnosis and treatment. Building on existing infrastructures, the EU cancer plan should support capacity-building and interoperable frameworks that enable data to flow within and between countries in the interest of patient care. The digitisation also calls for enhanced cooperation in the field of education and training to ensure the medical profession is equipped with advanced skills for healthcare professionals to offer the best care to patients. The EU cancer plan should therefore stimulate capacity-building and the integration of AI and digital skills into medical training. Moreover, Europe’s Beating Cancer Plan should capitalise on existing frameworks to pool expertise and knowledge in the diagnosis and treatment of cancer. It is therefore essential to invest in a sustainable (financial) framework for the European Reference Networks in order to advance cross-border healthcare and specialised collaboration on rare cancers. Once again, the EU cancer plan should be complementary to the EU cancer mission and other R&D programmes to target specific and unmet needs in cancer care, whereas realistic and measureable deliverables should be identified to allow for monitoring and adjustments.
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Meeting with Gonzalo De Mendoza Asensi (Cabinet of Vice-President Miguel Arias Cañete)

13 Nov 2015 · Presentation of the ESR activities - follow up

Meeting with Gonzalo De Mendoza Asensi (Cabinet of Vice-President Miguel Arias Cañete)

17 Jun 2015 · Presentation of ESR activities