OpenLobby.EU
Explore

European University Hospital Alliance

EUHA

EUHA’s vision is to build a network of sustainable healthcare ecosystems in Europe which achieve the best possible quality of care with the resources available.

Lobbying Activity

Meeting with Olivér Várhelyi (Commissioner) and

13 Oct 2025 · Forward looking approaches in hospital care

Meeting with Kasia Jurczak (Head of Unit Research and Innovation)

26 Sept 2025 · EU Life Sciences Strategy and Clinical Research Investment Plan

Meeting with Kasia Jurczak (Head of Unit Research and Innovation)

15 May 2025 · Presentation of the EUHA and a discussion on their role as a network of clinical research hospitals supporting multi-country clinical trials within the EU.

Response to EU rules on medical devices and in vitro diagnostics - targeted evaluation

19 Mar 2025

EUHA is a network of 11 leading European university hospitals renowned for their excellence in healthcare, education, research & innovation. The university hospitals we represent are committed to enhancing the quality of care, improving patient health and promoting well-being. EUHA recognises the importance of the MDR/IVDR regulations in creating a strong framework that prioritises patient safety while supporting innovation. Together we represent the interest of more than 19,400,000 patients and 273,200 colleagues who are all influenced by the MDR&IVDR. One of the main concerns of EUHA, next to availability of medical devices, is the impact of the regulations on innovation: University hospitals play not only a vital role in delivering healthcare but also drive medical research and innovation by closing gaps in understanding complex diseases, orphan diagnostic challenges alongside exploring new technologies and medicines. Addressing these challenges requires significant time and resources and subsequently hospitals face significant resource burdens to meet rigorous documentation- and compliance standards. This letter introduces the challenges we face as health institutions due to the current MDR/IVDR legislation and highlights the proposed adaptations centred on the needs of patients across Europe in our field of work. To support this letter, we will send an extended version by mail which contains more detailed description of our proposed suggestions: Availability of Medical Devices: The transition to MDR&IVDR has caused critical delays in certification, leading to shortages and reduced variety of devices, especially in academic hospitals treating rare diseases. The extension of transitional rules is only a temporary fix, and action is needed for a longer-term solution. Innovation: Stringent MDR and IVDR requirements are stifling innovation by imposing significant regulatory and administrative burdens, causing delays and increased costs. Adjustments are required to balance compliance with the urgent need for innovation. Harmonization: While MDR/IVDR aim to harmonize regulations across the EU, varying levels of preparedness among member states are causing significant challenges. Therefore, harmonization issues between member states hinders innovation and collaboration between healthcare institutions in the EU. Urgent, continuous collaboration between national authorities is essential for effective harmonization. Interpretation and Clarification: The current regulation leads to a lack of clarity for healthcare institutions on important topics such as transition periods and conformity of medical devices on the market. For in-house development, Article 5.5 of the IVDR and MDR requires urgent clarification to ensure consistent interpretation among member states and ensure continuous collaboration between healthcare institutions. Clinical Trials, Clinical Investigations, and Performance Studies: Despite stricter regulatory requirements, there is an urgent decline in numbers of clinical investigations within the EU, resulting in new innovations being tested outside the EU. This limits access to innovative devices for EU patients and requires immediate attention. To conclude, recognizing the critical role of university healthcare institutions within the area, EUHA can ensure that university hospitals collectively provide valuable input on legislation and contribute to addressing the current challenges. Therefore, we call on European decision and policy makers to acknowledge the European university hospitals as stakeholders in the development and review of MDCG documents as well as being included in the revision process of the MDR & IVDR as foreseen in article 121 MDR & article 111 IVDR. EUHA would be pleased to engage in conversation with you to discuss how the regulation could be improved to promote effective and efficient implementation by the researchers, innovators and healthcare workers in the academic health sector in Europe.
Read full response

Meeting with Oliver Schenk (Member of the European Parliament) and All Policies for a Healthy Europe

18 Dec 2024 · European Health Policy

Meeting with Stine Bosse (Member of the European Parliament, Committee chair) and DIGITALEUROPE and

10 Dec 2024 · European health policy

Meeting with Riikka Torppa (Cabinet of Commissioner Elisa Ferreira)

25 Jul 2023 · Technical support instrument - facilitating reforms in the health sector in EU Member States

Response to A European Health Data Space

3 Feb 2021

The Digital Health and Data Network (DHDN) of the European University Hospital Alliance (EUHA, an association of nine leading university hospitals in Europe) welcomes the initiative of a European Health Data Space and looks forward to working together on its design and implementation. In addition to the use of data for better medicine and effective medical research, the protection of citizens and the promotion of scientific progress should go hand in hand. Digital medicine means using structured data together in real time! The importance of access to such data use has just been shown to us all again by the COVID-19 pandemic. It is not enough to simply bring data together - robust structures must also be created for data protection-compliant use, as well as tools for efficient collaboration (such as messenger systems), including across borders, and the involvement of citizens. We will support the project with all our expertise and gladly accompany the further steps! On behalf of the European University Hospital Alliance, Dr Peter Gocke, EUHA coordinator of the DHDN, and Ms Lynn Seveke, EUHA Alliance Manager
Read full response

Response to Europe’s Beating Cancer Plan

3 Mar 2020

The European University Hospital Alliance* (EUHA) consists of nine of Europe’s leading university hospitals from nine countries. EUHA welcomes the initiative to develop Europe’s Beating Cancer Plan and the comprehensive approach from prevention to people’s life post-cancer, especially seen in connection with the Mission on Cancer in Horizon Europe. Important issues that university hospitals play an active role in such as the need for data sharing, communication with patients about data usage, continuity of care, establishment of outcome measurements, patient empowerment and centeredness, availability and affordability of technologies, clinical trial cooperation, personalized screening, treatment and production, rare cancers, cancer as a chronic disease and others are well covered. EUHA RECOMMENDATION: EUHA calls upon the European Commission to incorporate a focus on the importance of science-driven, active and structured “translation” of new methods and knowledge in the field of cancer into healthcare practice. New understandings of cancer causation and mechanisms and new diagnostic and therapeutic methods will continue to emerge. They will come from research and will need to be evaluated in respect to real life value for patients and eventually integrated into patient care. These new understandings and methods will require the adaptation of healthcare settings and most likely also the development of new structures, processes, networks and specializations to best harness the opportunities these developments offer in an economically viable manner. The design of future developments in the organisation, processes, networking and training of cancer care providers should be informed by scientific analyses of their effectivity, efficacy and socio-cultural impact and be governed by a best-practise approach encompassing all of Europe to ensure the best possible and economical feasible care for all patients/citizens, instead of being externally driven by the new developments. This also would give Europe a chance to position cancer care as a possible future field of excellence for Europe and could affect European citizen’ satisfaction with European and national healthcare programmes and structures. It also directly affects the important interface between research and healthcare, as it would strengthen and accelerate the assessment and eventual uptake of new knowledge and methods into patient care in Europe and therefore might boost European research in the field. New aspects of cancer care will be first tested and evaluated in academic healthcare settings and these institutions will often be the first to implement them eventually and strive to do this with a patient centered and science-led development of the best organisation, processes, networking and training for the usage of new knowledge and methods for patients. EUHA, as an organisation of European University Hospitals, is fully committed to ‘beating cancer’ and is looking forward to play an active role in this important initiative for European citizens, patients, research and healthcare providers. *The members of the European University Hospital Alliance are: Allgemeines Krankenhaus der Stadt Wien and the Medical University Vienna; Assistance Publique – Hôpitaux de Paris; Charité Universitätsmedizin Berlin; Erasmus University Medical Centre; Karolinska University Hospital; King’s Health Partners; Ospedale San Raffaele; University Hospitals Leuven and Vall d’Hebron Barcelona University Hospital Campus
Read full response

Meeting with Anne Bucher (Director-General Health and Food Safety)

4 Dec 2019 · Participation in General Assembly, speaking on : upcoming EU priorities for health, relationships with stakeholders. How EUHA could help achieve goals – what do university hospitals need.