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Siemens Healthineers AG

SHS

Siemens Healthineers develops, makes and sells medical devices, diagnostic products and radiotherapy solutions.

Lobbying Activity

Meeting with Malgorzata Nikowska (Head of Unit Communications Networks, Content and Technology), Saila Rinne (Head of Unit Communications Networks, Content and Technology)

15 Dec 2025 · Exchange on MedTech in Europe

Meeting with Olivér Várhelyi (Commissioner) and

1 Dec 2025 · Digital and AI as an enabler in healthcare

Siemens Healthineers urges EU to align circularity rules

6 Nov 2025
Topic — The Circular Economy Act aims to improve EU sustainability and economic security through better recycling.
Message — They want policy alignment to enable the reuse of medical devices and parts. They also advocate for using public procurement to boost demand for refurbished equipment.123
Why — This would lower costs by enabling the company to reuse complex components and plan investments.4
Impact — Vendors of new medical equipment lose the protection of procurement rules that exclude refurbished goods.5
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Meeting with Andreas Glück (Member of the European Parliament)

30 Oct 2025 · Environment Policy

Siemens Healthineers Urges Sectoral AI Rules to Safeguard Medical Innovation

14 Oct 2025
Topic — The EU is seeking feedback on simplifying digital regulations to reduce administrative burdens.
Message — The company advocates for a sectoral approach that integrates AI Act requirements into existing medical device regulations. They request exemptions for legacy devices from retroactive rules and call for data sharing to be voluntary by default. Additionally, they propose a harmonised, one-stop platform for all cybersecurity incident reporting.123
Why — This would significantly lower compliance costs and prevent the costly redesign of long-standing products.45
Impact — Smaller developers and researchers lose guaranteed access to proprietary healthcare datasets for innovation.67
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Meeting with Axel Hellman (Cabinet of Commissioner Jessika Roswall) and European Coordination Committee of the Radiological, Electromedical and healthcare IT Industry and GE HealthCare Technologies Inc

14 Oct 2025 · Challenges in the supply chain for medical imaging devices Regulation of hazardous substances and their impact on competitiveness of the medical device sector

Meeting with Hanna Anttilainen (Cabinet of Executive Vice-President Stéphane Séjourné)

14 Oct 2025 · Challenges faced by the medical devices industry

Meeting with Agata Gerba (Head of Unit Trade)

13 Oct 2025 · Discussion on barriers to the international operations of the company

Meeting with Olivér Várhelyi (Commissioner) and

13 Oct 2025 · Competitiveness of the EU health industry sector

Meeting with Cecile Billaux (Head of Unit Directorate-General for International Partnerships)

10 Oct 2025 · Overview of Siemens Healthineers’ actions in global health and in Africa

Meeting with Marco Chirullo (Acting Head of Unit Trade)

9 Oct 2025 · Impact of China's Export Controls on Siemens Healthineers' Business Operations

Siemens Healthineers urges shift to surveillance-based device certification

6 Oct 2025
Topic — The European Commission is evaluating the efficiency and competitiveness of medical device regulations.
Message — Siemens Healthineers proposes replacing fixed-term recertifications with a surveillance-based approach to maintain certificate validity. They also want purely administrative changes excluded from full certification to reduce unnecessary market delays.12
Why — Reducing recertification requirements would significantly lower administrative costs and expedite market entry.34
Impact — Patient safety advocates may lose the rigorous oversight provided by mandatory five-year device recertifications.5
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Siemens Healthineers Urges Simpler CBAM Rules for Medical Technology

24 Sept 2025
Topic — The consultation defines the methodology for calculating embedded emissions during the CBAM definitive period.
Message — The company requests a simplified two-page calculation model to accommodate complex medical products. They also advocate for the permanent use of default emission values with capped penalty markups.123
Why — Simplified rules would reduce administrative burdens and resolve data collection issues with foreign suppliers.45
Impact — Climate monitoring efforts lose accuracy if companies use generic default values instead of reporting actual emissions.6
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Meeting with Victor Negrescu (Member of the European Parliament) and FTI Consulting Belgium and

23 Sept 2025 · Meeting with MedTech Europe Cardiovascular Sector Group

Meeting with Ekaterina Zaharieva (Commissioner) and

19 Sept 2025 · Life science strategy and medical device technologies

Siemens Healthineers Urges €5 Billion EU Cardiovascular Health Plan

17 Sept 2025
Topic — The European Commission is consulting on a dedicated cardiovascular health strategy.
Message — The company proposes a comprehensive European plan with mandatory national strategies and a €5 billion budget. They request a leaner regulatory framework to accelerate adoption of digital tools.12
Why — New EU funding and digital standards would drive demand for their medical imaging and AI products.34
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Siemens Healthineers urges EU to exempt medical technology from CBAM

26 Aug 2025
Topic — The EU is consulting on expanding carbon border taxes to downstream goods.
Message — Siemens Healthineers requests that medical technologies remain exempt from the carbon border tax. They argue tracking emissions across complex supply chains is practically unattainable. The company recommends postponing any scope expansion until at least 2028.123
Why — An exemption would prevent a massive increase in reporting costs and bureaucracy.4
Impact — Patients lose as compliance costs divert resources away from innovation and care.5
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Meeting with Angelika Niebler (Member of the European Parliament)

8 Jul 2025 · US-Tariffs

Meeting with Patricia Reilly (Cabinet of President Ursula von der Leyen)

10 Jun 2025 · Future outlook for Medtech sector

Siemens Healthineers urges sectoral shift for medical AI rules

4 Jun 2025
Topic — The Commission is seeking views on boosting industrial AI use and productivity.
Message — The company requests integrating AI Act requirements into existing medical device regulations. They also propose delaying the application date for the sector until 2029.12
Why — This would lower compliance costs and resolve legal uncertainties caused by conflicting regulations.3
Impact — Patients may suffer from health risks due to delays in accessing new technologies.4
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Meeting with Hana Genorio (Cabinet of Commissioner Jozef Síkela), Lucie Šestáková (Cabinet of Commissioner Jozef Síkela)

8 May 2025 · Introductory discussion and opportunities for cooperation

Meeting with Angelika Niebler (Member of the European Parliament)

25 Apr 2025 · Health care policy

Meeting with Fausto Matos (Cabinet of Executive Vice-President Henna Virkkunen)

19 Mar 2025 · Artificial Intelligence in the health sector

Response to Health technology assessment – Joint scientific consultations on medical devices and in vitro diagnostic medical devic

26 Nov 2024

Siemens Healthineers welcomes the opportunity to provide input on the draft implementing act (IA) for joint scientific consultations (JSCs) on medical devices and in vitro diagnostic medical devices (IVDs). Please see the attached file. Joint scientific consultations are a critical component of Regulation (EU) 2021/2282 on health technology assessment (HTA-R), particularly for medical devices and IVDs. These encompass a wide variety of technologies that differ vastly in their use cases and potential PICOs yet are facing complex evidence generation. Some domains of HTA such as organisational aspects, even if unspecific, are highly relevant for medical technologies. As outlined in recital (24) of Regulation (EU) 2021/2282: Methodologies for performing joint clinical assessments and joint scientific consultations should be adapted to include specificities of new health technologies for which some data may not be readily available. Although relevant for a variety of medical devices, diagnostic technologies are valid cases for this statement, where clinical utility evidence generally requested by HTAs to support decisionmaking at the national level may not be available for years after these technologies have been placed in the market, when their impact to avoid the occurrence of deterioration of medical conditions can effectively be measured. In this context, JSCs should be considered as the most significant opportunity to establish robust, transparent and streamlined dialogue between HTA agencies and health technology developers (HTDs), to facilitate evidence generation for technologies subject to joint clinical assessments (JCA), as outlined in Article 16 of the Regulation. We believe that the draft IA for JSCs however requires additional precisions to support an effective implementation of HTA-R, and would like to propose the following amendments be made to the IA to operationalise this intention: 1. Clarify the selection of technologiessubject to JCA and therefore JSC Issue: Uncertainty persists on the medical technologies to be subject to JCA, and therefore eligible for JSC, due to Article 7 (4) of HTA-R being specific to medical technologies. Criteria defined in this Article, such as unmet medical need, first-in-class technology, incorporation of software using artificial intelligence or machine learning, or significant cross-border dimensions, remain unspecified and do not confer the JCA and JSC processes sufficient predictability to meet the objectives of HTA-R. Proposal: Use the JSC IA as the opportunity to clarify these criteria, and to implement as part of the JSC a process for an HTD to confirm/exclude eligibility of their technology for a JCA. This should be implemented e.g. as a stepwise process where HTDs first obtain confirmation regarding the eligibility of their technology for a JCA, before deciding whether to request an actual JSC, and ultimately submitting for a JCA after evidence generation. 2. Allow for flexibility in the timelines of JSC and JCA Issue: Innovation in medical technologies results from the interaction between advancements in technology and their clinical implementation this implies that the criteria that make a technology eligible for JCA, and therefore JSC, may in some cases be met much after regulatory approval, once the technology is adopted in clinical practice. Furthermore, this aspect of novelty may apply to a class or category of technologies, rather than a single brand technology. A novel use case that meets the criteria of article 7(4) of Regulation (EU) 2021/2282 may also be made possible by incremental innovation in a pre-existing device class. Most of the technologies assessed during the EUnetHTA programme met one or more of the above exceptions. Proposal: We recommend for the IA to allow for JSC being conducted at any point in the technology lifecycle, and for more than one HTD in the same consultation process, where relevant. Furthermore,
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Meeting with Andreas Glück (Member of the European Parliament)

2 Oct 2024 · Health Policy

Meeting with András Tivadar Kulja (Member of the European Parliament)

2 Oct 2024 · Medical devices

Meeting with Mairead McGuinness (Commissioner) and

10 Sept 2024 · High-level executive roundtable: preventing the circumvention of EU sanctions on sensitive goods.

Meeting with Iuliu Winkler (Member of the European Parliament)

10 Sept 2024 · Trade priorities for this mandate

Meeting with Valdis Dombrovskis (Executive Vice-President) and BUSINESSEUROPE and

10 Sept 2024 · Preventing the circumvention of EU sanctions on sensitive goods

Meeting with Vytenis Povilas Andriukaitis (Member of the European Parliament)

18 Jul 2024 · Medical and care innovation

Meeting with Anna Cavazzini (Member of the European Parliament, Committee chair) and Apple Inc. and

23 Feb 2024 · Aktuelle Themen in der Europapolitik und Sachsen

Meeting with Maurits-Jan Prinz (Cabinet of Commissioner Thierry Breton) and Airbus and

7 Sept 2023 · discussion on AI Act

Meeting with Andreas Glück (Member of the European Parliament, Shadow rapporteur for opinion)

8 Feb 2023 · EHDS

Meeting with Maria da Graça Carvalho (Member of the European Parliament)

8 Feb 2023 · Health

Meeting with Pierre Delsaux (Director-General Health Emergency Preparedness and Response Authority)

8 Feb 2023 · Introduction of the Company.

Siemens Healthineers Demands Alignment With Existing Medical Device Rules

20 Jan 2023
Topic — A consultation on cybersecurity requirements for products with digital elements in the EU.
Message — They propose reusing existing medical frameworks and extending the 24-month transition period. They request 72-hour reporting windows to align with data protection rules. The firm advocates for shared responsibility across the healthcare value chain.123
Why — Reusing established health standards would prevent redundant certifications and reduce administrative costs.45
Impact — Regulators would face limits on fine amounts and public transparency during cyber incidents.67
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Meeting with Ibán García Del Blanco (Member of the European Parliament, Rapporteur) and Volkswagen Aktiengesellschaft and

29 Sept 2022 · Exchange of views on the Data Act

Meeting with Karen Melchior (Member of the European Parliament, Shadow rapporteur) and Orgalim – Europe's Technology Industries

23 Sept 2022 · Data Act

Meeting with Svenja Hahn (Member of the European Parliament, Shadow rapporteur) and MedTech Europe

31 Aug 2022 · Artificial Intelligence Act (AIA)

Siemens Healthineers Urges Harmonized Rules for Health Data Space

28 Jul 2022
Topic — This consultation addresses the creation of a European framework for sharing electronic health data.
Message — The company requests the EHDS clearly delineate the scope from other regulated product definitions to avoid inadvertent overlaps. They argue safeguards for the protection of intellectual property and trade secrets are insufficient. Finally, they suggest involving industry in the governance board to leverage expertise.1234
Why — This would reduce its compliance cost and protect the business value of its research.56
Impact — Independent researchers would lose access to valuable datasets if intellectual property safeguards are strengthened.7
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Siemens Healthineers warns Data Act could stifle medical innovation

13 May 2022
Topic — Consultation on legislation for fair access to and use of industrial data.
Message — The organization urges policymakers to protect trade secrets and narrow the broad definition of data. They advocate for sector-specific rules rather than a premature, one-size-fits-all regulatory intervention.12
Why — Restricting data sharing protects their proprietary medical software and maintains their market leadership.3
Impact — Tech competitors lose mandatory access to datasets needed to build competing health services.4
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Meeting with Dragoş Tudorache (Member of the European Parliament, Rapporteur)

10 May 2022 · Artificial Intelligence

Response to Cancer Screening Recommendation

22 Feb 2022

Please find our feedback in the attached file.
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Meeting with Kim Van Sparrentak (Member of the European Parliament)

15 Dec 2021 · AI Act

Meeting with Axel Voss (Member of the European Parliament) and RELX

17 Nov 2021 · Artificial Intelligence

Response to Requirements for Artificial Intelligence

6 Aug 2021

Siemens Healthineers welcomes the initiative of the European Commission to set a global benchmark for deployment of ethical and legal artificial intelligence (AI) applications. AI has already brought numerous advancements to the field of healthcare by providing assistance to medical professionals in tasks as diverse as diagnosis, treatment, therapy, monitoring patients’ health, and even the management of hospitals and care institutions. We are the global leader when it comes to AI patent applications in medical imaging and have been a pioneer in AI development for more than 20 years, providing significant means of support to healthcare professionals in complex diagnosis and optimised treatment, as well as further expanding precision medicine . Siemens Healthineers is proud to be contributing to solutions that support doctors in the fight against the Covid-19 pandemic, cancer, or in enabling early diagnosis of Alzheimer’s. Medical technology is instrumental for current healthcare systems that operate in synergy with doctors, nurses and other care providers. To ensure that only safe and performant devices are placed on the European market, all our technology is fully in line with the regulatory frameworks for medical devices already in place - the Medical Devices Regulation (MDR) and In-vitro Diagnostics Regulation (IVDR). These are robust, comprehensive and up-to-date frameworks that ensures legal certainty to all market players and society at large. They cover the entire cycle of the new medical product from development to placement on the market and putting into service, and continuous monitoring throughout its life cycle. Beyond the legal frameworks, Siemens Healthineers takes very seriously the responsibility towards end-users, especially patients, for placing safe and highly performing products on the European market very seriously. We strongly support the existing frameworks for medical devices, which already lay down distinct requirements for medical devices software, and in particular AI. As such, we recommend keeping addressing the specificity required by the medical device sector through the dedicated medical devices frameworks. This would best serve the twin purpose of ensuring legal certainty for European manufacturers and fully protecting end-users through tailored regulation that specifically addresses AI in medical devices. The existing rules already provide stringent regulations for the use of devices – including AI - in healthcare. We therefore oppose a-size-fits-all approach in law-making, which lacks the specificity to guarantee the highest level of safety in medical devices. If any gaps in existing rules should emerge as AI develops, they can and should be addressed by supplementing sector-specific rules and not through horizontal regulation.  Moreover, it is noteworthy, that despite the enormous potential for healthcare innovation in Europe, it is evident that other jurisdictions, have become the preferred location to first place innovative medical software on the market. We are deeply concerned that the proposed Regulation on Artificial Intelligence (AI Act), would further accelerate this process, and result in (i) stifling the development of innovative solutions in Europe, (ii) increasing the costs for healthcare systems, and (iii) most seriously, potentially depriving European patients and citizens of access to state-of-the-art digital health technology. We therefore believe that the proposal requires further consideration, and improvements, which we briefly present in our attached analysis.
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Response to Liability rules for Artificial Intelligence – The Artificial Intelligence Liability Directive (AILD)

28 Jul 2021

Siemens Healthineers welcomes the opportunity to provide input to the Commission's plan to adapt the liability rules against the background of new technology developments and artificial intelligence (AI). From a Siemens Healthineers perspective, AI as a technology used in medical devices per se does not pose any danger or harm. It is a tool that serves a human-defined purpose: in the context of healthcare, AI-based algorithms are used to support clinical decision-making by providing additional sources of information. It is important to emphasize that the manner AI is used, and decisions made with the aid of AI-enabled tools always rest with healthcare professionals (HCPs). In other words, AI supports HPCs, who always have the “final” say. While we understand the broad aim of the Commission to provide more legal certainty, we would like to underline that the safety of medical devices (in vitro and in vivo) has been of great importance for years and continuously is, as reflected in particular by the recent issuance of the Medical Devices Regulation (Regulation (EU) 2017/745 on medical devices (MDR)) and the In Vitro Diagnostic Medical Devices Regulation (Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)). Due to importance of the healthcare sector and duty to ensure devices’ safety and functional performing, devices are not placed on the market unless they have achieved a substantiated indication that they are safe and secure to be used with patients. For that very reason, there is little litigation: the industry simply cannot afford to place defective products as the consequences may be disastrous. If the damage relates to data and privacy, GDPR is deemed to provide an individual with adequate means for redress. Expanding the scope of liability towards privacy, data, environment – would increase legal uncertainty over which piece of legislation one has to comply with and would make medtech industry uninsurable. Non-pecuniary damage (e.g., for pain, suffering), on the other hand, is already provided for by the domestic laws, while the root for such claim would be grounded in PLD. It is noteworthy, that the assessment carried out for the Commission found that MDR and IVDR are fit for the digital age by being a “very modern piece of legislation that fully takes into account the specificities of software. In particular, it recognises that safety includes safety throughout the device lifecycle and in all environments in which the device is foreseeably going to be used; fully recognises the need for post-market surveillance and contemplates the possibility that the best way to eliminate a safety risk may be to take positive action and provide repair (i.e. a software update); provides rules for distinguishing between software updates that require an entirely new safety assessment and updates that require only limited action; and explicitly explains who is responsible for what in an ecosystem of various stakeholders involved ”, even in the case of refurbishment. In view of the above, we are confident that the current liability regime for medtech sector is sufficient and no further regulation is needed.
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Meeting with Thierry Breton (Commissioner) and

16 Feb 2021 · Pact for Skills roundtable with the representatives of the health sector

Meeting with Nicolas Schmit (Commissioner) and

16 Feb 2021 · Pact for Skills roundtable with the representatives of the health sector.

Meeting with Roberto Viola (Director-General Communications Networks, Content and Technology)

19 Jan 2021 · Digital health response to the Covid pandemic (video meeting)

Response to Evaluation of the 'New Legislative Framework' for EU legislation on industrial products

2 Dec 2020

Siemens Healthineers very much welcomes the European Commission’s recent initiative to evaluate the New Legislative Framework regarding it being fit for purpose in a digital and circular economy. We are going to contribute actively to the further consultations and would be very glad to be involved in further activities such as interviews, surveys and workshops. The European Commission’s recent initiative of reviewing the EU Blue Guide has been very much appreciated and the additional paragraphs on reuse, repair and life time extension are going to add clarity and pave the way for future improvements of the EU legislative framework. At the same time, it seems that the most challenging issue in the context of the refurbished medical imaging devices could not be solved in the EU Blue Guide revision yet, which is providing to identical refurbished medical devices the same regulatory requirements regardless of where they have been placed on the market before refurbishment (inside the EU or outside the EU). We hope an improved legislative framework will recognize the case of placing on the market requirements for refurbished devices which had not been placed on the EU market before refurbishment and provide them equal access to the EU internal market as refurbished devices which had been placed in the EU market before refurbishment. We believe that this will further improve access to quality healthcare and to fully unfold the full potential of the circular economy in Europe in the future. Siemens Healthineers supports the comments provided by the industry association COCIR and refers to further details in this regard.
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Meeting with Thierry Breton (Commissioner) and SANOFI and

6 Apr 2020 · Digitisation of healthcare and innovative e-health solutions.

Meeting with Koen Doens (Director-General Directorate-General for International Partnerships)

3 Mar 2020 · Meeting with President Europe, Middle East and Africa

Meeting with Sandra Bartelt (Cabinet of Commissioner Jutta Urpilainen)

3 Mar 2020 · Economic diplomacy and investment regarding sustainable health systems in African countries. Forthcoming Africa strategy and creation of jobs and growth in Africa.

Meeting with Roberto Viola (Director-General Communications Networks, Content and Technology)

3 Mar 2020 · Digital transformation of health and care