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Edwards Lifesciences

EW

Edwards Lifesciences is a global medical technology company specializing in innovations for structural heart disease.

Lobbying Activity

Meeting with Sirpa Pietikäinen (Member of the European Parliament)

14 Nov 2025 · Health technology, heart and CVD

Meeting with Christophe Grudler (Member of the European Parliament)

13 Nov 2025 · Politique industrielle européenne

Meeting with Seán Kelly (Member of the European Parliament)

13 Nov 2025 · Supports and opportunities in the med-tech sector in Ireland

Edwards Lifesciences Urges Dedicated EU Budget for Cardiovascular Health

12 Nov 2025
Topic — This consultation covers EU funds supporting EU competitiveness within the next long-term budget.
Message — They request a specific budget for heart health by pooling various existing funds. The group advocates for investments that help hospitals adopt innovative medical devices. They also propose establishing European centers of excellence to improve infrastructure and training.123
Why — This dedicated funding would expand the market for the company’s heart valve innovations.4
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Meeting with Victor Negrescu (Member of the European Parliament) and American Chamber of Commerce to the European Union and

8 Oct 2025 · AmCham EU Healthcare Committee Meeting

Edwards Lifesciences Urges Fast-Track Path for Breakthrough Innovations

6 Oct 2025
Topic — A targeted revision of EU rules governing medical devices and in-vitro diagnostics.
Message — The company proposes an EU designation and a 120-day priority review for breakthrough technologies. They also advocate for conditional marking to accelerate access to innovative implantable devices.12
Why — Faster approvals would help the company maintain its competitive edge and reduce costs.3
Impact — Transparency groups could lose access to data if reporting obligations are removed.4
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Response to European Innovation Act

3 Oct 2025

Edwards Lifesciences welcomes the proposal for the European Innovation Act as a timely and strategic initiative to accelerate the uptake of breakthrough innovation and strengthen Europes industrial competitiveness. As a global leader in structural heart innovations, Edwards sees this as an important opportunity to modernise the EUs innovation ecosystem and address longstanding barriers that are holding back high-impact breakthrough medical technology from reaching patients in a timely and predictable manner. At the core of the Innovation Acts ambition is the need to move faster from research to result. Edwards strongly supports this vision. Our experience in the medical technology sector highlights that the barriers are not necessarily linked to invention, but to scale-up, uptake, and deployment. Fragmented regulatory frameworks, limited publicprivate partnerships and investments, procurement systems that reward lowest cost rather than best outcomes, restricted access to finance, and weak coordination between EU and national policies all combine to slow down the journey of innovation from lab to patient. The Innovation Act is therefore an opportunity to deliver a comprehensive framework for innovation in Europe. This framework should integrate support ongoing EU efforts in the space of regulatory efficiency, financing, procurement, partnerships, talent, and coordination to strengthen Europes position as a global hub for life sciences and health technologies. Edwards calls for an end-to-end pathways for breakthrough innovation in healthcare: Introduce accelerated, priority review regulatory pathways (MDR) Setting adaptive HTA methodologies Enhancing PublicPrivate Partnerships (PPPs). Expanding Value-Based Public Procurement (VBP) Dedicated investments into uptake of innovations
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Edwards Lifesciences Urges EU Action on Heart Disease Innovation

12 Sept 2025
Topic — Consultation on a new European Union plan for cardiovascular health.
Message — The company calls for European screening programs and clear patient referral pathways. They recommend creating a network of cardiovascular excellence centers and accelerating device approvals.123
Why — Faster regulatory reviews and increased funding would speed up market entry for their products.45
Impact — Patients suffer from life-threatening delays because of limited hospital capacity and long waiting lists.6
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Meeting with Carmen Laplaza Santos (Head of Unit Research and Innovation)

24 Jul 2025 · Discussion on the importance of innovation in the medical devices sector

Edwards Lifesciences seeks faster EU pathways for heart technologies

17 Apr 2025
Topic — The EU is developing a strategy to boost the competitiveness of life sciences.
Message — The company calls for a 120-day priority review process for breakthrough medical devices. They advocate for adapted assessment methods that include real-world evidence and clinical data. They suggest shifting public purchasing to a value-based model to reward innovation.123
Why — Faster approval times would allow the company to bring heart technologies to market quicker.4
Impact — Vulnerable patients suffer when slow regulatory and procurement processes delay access to treatments.5
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Meeting with Oliver Schenk (Member of the European Parliament) and European Union of Private Hospitals

8 Apr 2025 · Workforce shortages

Meeting with Niels Geuking (Member of the European Parliament)

7 May 2024 · Herz-Kreislauferkrankungen / Gesundheit

Meeting with Karolina Herbout-Borczak (Cabinet of Commissioner Stella Kyriakides), Ralf Kuhne (Cabinet of Commissioner Stella Kyriakides) and

11 Apr 2024 · Meeting with representatives from the Medtech Europe Cardiovascular sector group.

Meeting with Olivier Chastel (Member of the European Parliament) and RPP Group

22 Feb 2024 · Presentation Groupe de travail pénurie personnel de santé et les moyens d'y répondre

Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur) and BioMarin UK Limited

30 Jan 2024 · Pharma legislation

Meeting with Deirdre Clune (Member of the European Parliament)

15 Nov 2023 · Innovation & Patient Access to Medicines

Meeting with Maria da Graça Carvalho (Member of the European Parliament) and FTI Consulting Belgium and

7 Nov 2023 · Cardiovascular Health

Meeting with Tiemo Wölken (Member of the European Parliament, Rapporteur) and RPP Group and European Social Insurance Platform AISBL

18 Jul 2023 · Revision of the Pharmaceutical Legislation (staff level)

Edwards Lifesciences demands priority review for medical devices

17 Jul 2023
Topic — Revision of EU pharmaceutical legislation to improve access and innovation.
Message — The organization requests extending priority review and enhanced scientific support to medical devices addressing unmet needs. They propose a 150-day conformity assessment timeline to match accelerated pharmaceutical procedures.12
Why — Faster approvals would help the company bring innovative heart technologies to market more quickly.34
Impact — Patients requiring innovative devices face unfair delays compared to those treated with pharmaceuticals.56
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Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur) and American Chamber of Commerce to the European Union and

11 Jul 2023 · Directive on Medicinal products for human use

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur)

21 Jun 2023 · Directive on Medicinal products for human use

Meeting with César Luena (Member of the European Parliament)

14 Feb 2023 · MEP Luena's Team on Medical Devices Regulation

Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur)

9 Feb 2023 · SoHO

Response to Extension of the transition period for medical devices

18 Jan 2023

With the proposal for a Regulation (2023/0005) submitted on January 6, 2023 extending the transition period of the EU regulations on medical devices, the European Commission is working to ensure smooth implementation of its regulatory framework for medical devices, ensuring their availability, safety and effectiveness. While we acknowledge and support the Commissions proposals primary purpose is the deadline extension, the setting of a dedicated process to ensure that breakthrough innovations which address an unmet need reach patients fast enough is still missed. The proposed regulation is an opportunity to be forward-thinking and better support patients in Europe that today are lacking access to innovation that can save or significantly improve their lives. Adopting a specific process that allows to prioritize the review of certain breakthrough technologies will help to ensure that these devices are brought to the patient earlier, while securing the highest level of safety and best clinical evidence at different stages of the clinical development and utilization. Such a dedicated process with clear scope, criteria and timelines - does not yet exist in the EU, whilst it exists in other regions or countries (US, UK) or for other healthcare products (such as pharmaceuticals). Not having an EU priority review process for medical devices creates an inequality for patients that need access to treatment based on medical devices rather than medication, or that are based in the EU rather than outside the EU. It also hampers the EU attractiveness in terms of research, clinical and innovation excellence. Therefore, although the current proposal is key to ensure continued availability of existing medical devices, we call upon European Institutions to leverage the current proposals and look specifically to how certain breakthrough innovations can be evaluated through a dedicated priority review process.
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Meeting with Frances Fitzgerald (Member of the European Parliament)

16 Nov 2022 · MDR

Meeting with Seán Kelly (Member of the European Parliament)

10 Nov 2022 · EU Non-Communicable Disease Initiative ‘Healthier Together’

Meeting with Jakob Wegener Friis (Cabinet of Commissioner Paolo Gentiloni), Julia Lemke (Cabinet of Commissioner Paolo Gentiloni)

27 Oct 2022 · InvestEU programme and implementation of the Sustainable Europe Investment Plan

Response to A European Health Data Space

3 Feb 2021

Edwards Lifesciences is a global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring for critically ill patients. More specifically, for the management of critically ill patients, Edwards Lifesciences develops predictive monitoring solutions. These digital tools allow healthcare providers to predict and proactively treat incidents, such as a critical drop in blood pressure, before it happens, ensuring better patient outcomes from high-risk surgery and / or during the ICU or ER stay. The COVID-19 pandemic has put unprecedented pressure on our healthcare systems and healthcare organizations. One year after the first cases of COVID-19 were identified, hospitals in the European Union are still facing over-crowded ICU units and extremely thinly spread healthcare personnel. This has led to severe interruptions of care both during the first and second prolonged waves. As a result, overall health has worsened and severe increase in death has been recorded. Still today, many hospitals are struggling to maintain continuity for critical, potentially life-saving interventions and to secure effective critical patient monitoring. The struggles around the management and containment of the C-19 pandemic laid bare many inefficiencies in the way hospitals and our broader healthcare system are run. At the same time, the pandemic has even the more accelerated the demand for and offer of digital solutions – ranging from digital tools to accompany and monitor patients, to digital solutions to support healthcare professionals and enable them to deliver care in a safe and efficient manner. Predictive monitoring plays an essential part here. With this enhanced drive towards digitalization, the EU Commission’s “European Strategy for Data” , the Data Governance Act, and the specific European Digital Health Data Space initiative form essential pillars to accompany digital healthcare transformation, and spur innovation in the development of new treatments in the European healthcare sector, whilst respecting patient’s rights. Edwards Lifesciences supports these initiatives as they can support to drive benefits of health data and opportunities linked to hospital digitalization. In order to maximise the added-value of digital solutions to improve hospital efficiencies and deliveries, it is important to consider the dependency of the medtech industry’s ability to successfully access, aggregate, appropriately utilize health data and provide health data to clinicians and patients. Today, setting a most economically advantageous patient hospital journey from the emergency room, via the operating room, and through to the intensive care units remains a challenge and healthcare providers can benefit from the exchange of health data to drive hospital optimization and spur adoption of continuous learning technology. Already today, digital patient monitoring platforms developed with machine learning, that are deployed in a hospital setting, can predict adverse health events. More precisely, predictive monitoring platforms in critically ill patients can improve patient outcomes (e.g. critical drop in blood pressure) and drive hospital efficiencies. Utilizing digital health data or medical devices in which health data is embedded can play a role and can contribute to resource savings by limiting overall hospital stays, removing process bottlenecks, reducing ICU stays and, most importantly, limiting trauma and complications to patients’ conditions. The time is now to benefit from the opportunities of the implementing European health data initiatives, EU funded pilot projects through Digital Europe or Horizon Europe could play a strong push to promote tangible digitalization of healthcare systems, and patient pathways, without waiting for the development of a new regulatory framework.
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Response to Proposal for a Regulation establishing a European Centre for Disease Prevention and Control (ECDC)

2 Feb 2021

Edwards Lifesciences is a global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring for critically ill patients. We welcome the EU Commission’s initiative strengthen the mandate of the European Centre for Disease Control and Prevention (ECDC). The COVID-19 pandemic exposed us to the extremely concerning situation where hospitals are exposed to unmanageable pressures, in particular the ICU, ultimately leading to disruptions of elective care for patients suffering from other diseases, such as structural heart diseases. We would therefore support that the ECDC strengthens its capacity to monitor and assess how healthcare systems, and hospitals, can improve their preparedness and efficiency. This should help to better manage capacities and care when a future health threat occurs.
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Response to Proposal for a Regulation on serious cross-border threats to health

2 Feb 2021

Edwards Lifesciences is a global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring for critically ill patients. We welcome the EU Commission’s initiative update current rules on serious cross-border health threats to health. Indeed, the COVID-19 pandemic has acted as a magnifying lens showing that EU collaboration and exchange of information should be strengthened to better protect population’s health. Whereas the competencies for health remains mainly a national matter, we strongly believe that EU and Member States should collaborate more together to ramp up preparedness for future health threats, be more efficient in managing such complex threats when they occur and have better monitoring and reporting mechanisms in place to support evidence-based decision-making. The lesson learned from the COVID-19 is that healthcare systems and hospital capacities are facing unprecedented pressures creating a backlog in patients needing other care than urgent C-19 care. These severe disruptions in care continuity - for example for patients suffering from life-threatening structural heart diseases, such as heart valve disease - has led to the worsening of health of vulnerable populations, and an increase in deaths. (see references in separate document) We therefore strongly encourage the EU Commission to look at preparedness for health threats from a holistic perspective: Union-level and national plans (art 5-6 of proposal) to ensure continuity of care when a cross-border health threat occurs should be factored in. This will in turn avoid the unintended consequence of ill health and increased death in other disease areas. In addition, hospitals as such can be better supported to be prepared for any future crises, and to improve their efficiency. This can help a hospital to better take in additional patients when needed. Innovative medical technologies, such as minimal invasive technologies, can play a role in improving efficiencies as they can reduce length of stay, free up ICU capacities, and reduce the risk of infections for patients. Other medical technologies, such as digital predictive monitoring solutions can contribute to reducing the patients’ hospital footprint from the emergency room to the operating room to the ICU unit. Preparedness capacities of healthcare staff and hospitals should therefore not be limited to training of personnel when such a crisis occurs in future, but also incorporate the uptake of technologies and innovations that can improve the general efficiency of a hospital and its staff (art 11). Linked to this, when buyers are preparing to procure technologies – especially when it comes to joint procurements – the value that these medical technologies bring to the healthcare system and hospital efficiencies should be factored in (art 12). With the EU Health Union package, the EU Commission has a unique opportunity to support its Member States in protecting its citizens and enable a holistic approach to the better preparedness and management of cross-border health threats. By working together and exchange more strategically in which ways hospitals can become more efficient and resilient to such crises, the broader population, and especially patients suffering from life-threatening diseases, will be better protected.
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Response to Proposal for a Regulation on a Union framework addressing public health emergencies (EMA)

2 Feb 2021

Edwards Lifesciences is a global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring for critically ill patients. Edwards Lifesciences EMEACLA welcomes the EU Commission’s initiative to strengthen the role of the European Medicines Agency (EMA) to better address public health emergencies. Diseases have no borders, and nor should our response to tackling them. The current fragmentation has shown fragilities in the way we manage our healthcare systems, and the COVID-19 pandemic has acted as a lens showing where a strengthened approach could be appropriate. A strengthened role for the EMA to be able to better support Member States and EU Institution to prepare, manage and overcome public health emergencies can be a key pillar. We refer to our statement in attachment for a detailed position and references that support this position. In short, we would like to reiterate that: (1) A key element to ensure better crisis preparedness, and coordination should focus on minimizing any disruptions of care services for patients suffering from life-threatening diseases or needing to undergo surgery. It should at all prices be avoided that care is discontinued, as is still the reality one year after the COVID-19 pandemic hit Europe. Indeed in the first wave of the pandemic, we already witnessed a 50% decrease in the number of people with heart-related symptoms checking into hospitals. (2) Building European knowledge on the evidence generation path for high-risk complex implantable medical devices and secure timely adoption of innovation for patients will be critical to ensure that European patients can have access to the state-of-the-art medical innovation. Therefore, a clearer distinction between the role of EMA for medicines and for medical devices should therefore be foreseen. In this regard, alignment with the EU Medical Device Regulation and its timelines must be ensured. The role of the experts composing the expert panels should also be better clarified. More transparency and clarity on the functioning of expert panels, and how stakeholders can engage throughout the process and how deliberation will be foreseen. (3) We understand the objective of the proposal to remove uncertainty of supply and demand of essential medical devices during a future public health emergency. Indeed, shortages of such devices during crises could be detrimental to the safety of patients. Monitoring of stockpiling can help to avoid such a situation. However, it should be clarified that not all stocks that are manufactured or available in EU warehouses are intended for the supply of EU patients. Many manufacturers indeed base manufacturing or distribution in the EU but also export these stocks to other markets. As an active member of the EU Trade Association representing the medical technology industry in Europe, MedTech Europe, we further support the association’s feedback to the European Commission proposal and would like to refer to their statement for more detailed comments on the proposal. We stand ready to exchange with the European Commission to ensure that the EU Health Union package reaches its goal to support Member States to better prepare and manage health emergencies and ensure this is done in a holistic manner.
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