Medtronic

“Government and private sector initiatives to limit the growth of healthcare costs, including price regulation, competitive pricing, bidding and tender mechanics, coverage and payment policies, comparative effectiveness of therapies, technology assessments and managed-care arrangements, are continuing in many countries where we do business, including the U.S. These initiatives put increased emphasis on the delivery of more cost-effective medical devices and therapies.”

Annual report 2026A · The company itself

“Government programs, including Medicare and Medicaid, private healthcare insurance, managed-care plans, and volume-based procurement tenders in China, have attempted to control costs by limiting the amount of 10 Table of Contents reimbursement they will pay for particular procedures or treatments, tying reimbursement to outcomes, shifting to population health management, encouraging lower-cost sites of service, increasing use of utilization management programs (e.g., prior authorization), and other mechanisms. Hospitals, which purchase our technology, are also seeking to reduce costs through a variety of mechanisms, including, for example, centralized purchasing, and in some cases, limiting the number of vendors that may participate in the purchasing program.”

Annual report 2026A · The company itself

“Hospitals are also aligning interests with physicians through employment and other arrangements, such as gainsharing, where a hospital agrees with physicians to share any realized cost savings resulting from changes in practice patterns such as device standardization. This has created an increased level of price sensitivity among customers for our products.”

Annual report 2026A · The company itself

“Table of Contents CARDIOVASCULAR PORTFOLIO The Cardiovascular Portfolio is made up of the Cardiac Rhythm & Heart Failure, Structural Heart & Aortic, and Coronary & Peripheral Vascular divisions. The primary medical specialists who use our Cardiovascular products include electrophysiologists, implanting cardiologists, heart failure specialists, cardiovascular, cardiothoracic, and vascular surgeons, and interventional cardiologists and radiologists.”

Annual report 2026A · The company itself

“NEUROSCIENCE PORTFOLIO The Neuroscience Portfolio is made up of the Cranial & Spinal Technologies, Specialty Therapies, and Neuromodulation divisions. The primary medical specialists who use the products of this group include spinal surgeons, neurosurgeons, neurologists, pain management specialists, anesthesiologists, orthopedic surgeons, urologists, urogynecologists, interventional radiologists, and ear, nose, and throat specialists.”

Annual report 2026A · The company itself

“Products and therapies of this group are used primarily by healthcare systems, physicians' offices, ambulatory surgical centers (ASCs), and other alternate site healthcare providers. While less frequent, some products and therapies are also used in home settings.”

Annual report 2026A · The company itself

“The primary medical specialists who use and/or prescribe our Diabetes products are endocrinologists and primary care physicians.”

Annual report 2026A · The company itself

“Sales and Distribution We sell our medical devices and therapies through a combination of direct sales representatives and third parties (e.g., independent distributors and agents) globally. Additionally, a portion of the Company's revenue is generated from consignment inventory maintained at hospitals.”

Annual report 2026A · The company itself

“Regulations Governing Reimbursement The delivery of our devices is subject to regulation by the U.S. Department of HHS and comparable state and non-U.S. agencies responsible for reimbursement and regulation of healthcare items and services.”

Annual report 2026A · The company itself

“Our devices, products, and therapies are purchased principally by hospitals or physicians that typically bill various third-party payors, such as governmental healthcare programs (e.g., Medicare, Medicaid and comparable non-U.S. programs), private insurance plans and managed care plans, for the healthcare services provided to their patients. The ability of our customers to obtain appropriate reimbursement for products and services from third-party payors is critical because it affects which products customers purchase and the prices they are willing to pay.”

Annual report 2026A · The company itself

“Many healthcare industry companies, including healthcare systems, distributors, manufacturers, providers, and insurers, are consolidating or have formed strategic alliances. As the healthcare industry consolidates, competition to provide goods and services to industry participants will become more intense. Further, this consolidation creates larger enterprises with greater negotiating power, which can be used to negotiate price concessions.”

Annual report 2026A · The company itself

“In May 2025, the Company announced its intent to separate the Diabetes Business, with the intention to create a new independent, publicly traded company, MiniMed Group, Inc. (MiniMed). On March 9, 2026, MiniMed completed an initial public offering (the IPO).”

Annual report 2026A · The company itself

“As part of our strategy to develop and identify new products and technologies and optimize our portfolio of products, we have made several significant acquisitions, divestitures and third-party research and development funding arrangements in recent years, and may make additional acquisitions, divestitures and funding arrangements in the future. Our integration of the operations of acquired businesses, or a 15 Table of Contents divestiture of part of our existing businesses, including the ongoing separation of our Diabetes Business from the Company, requires significant efforts, including the coordination of information technologies, research and development, sales and marketing, operations, manufacturing, and finance.”

Annual report 2026A · The company itself

“Table of Contents In addition to competition from individual products or companies, rapid technological change may drive shifts in standards of care, physician preferences, purchasing decisions, or site of service dynamics more quickly than anticipated, including the growth of ASCs.”

Annual report 2026A · The company itself

“The techniques used to obtain unauthorized access to, or disrupt, information technology systems continue to evolve and may be further amplified by the use of AI and other emerging technologies by malicious actors. Like all organizations, we routinely experience attempted interference with the integrity of, and interruptions in, our technology systems via events such as cyber-attacks, malicious intrusions, or other breakdowns. The consequences of such an event could mean data breaches, interference with the integrity of our products and data, the compromising of our intellectual property or other proprietary information, operational disruptions, the need to implement manual processes or other temporary workarounds, or other significant disruptions.”

Annual report 2026A · The company itself

“We also face business and regulatory risks relating to our use of AI systems in our business operations and products. These systems are susceptible to flaws, biases, malfunctions or manipulations, which may disrupt our operations, result in erroneous decision-making, elevate our cyber risk profile, or expose us to penalties from non-compliance with emerging regulations.”

Annual report 2026A · The company itself

“Trade, export control, and other regulatory measures are increasingly targeted toward specific technologies and capabilities, such as software, digital health solutions, and AI-enabled tools, which could restrict our ability to develop, manufacture, deploy, service, or support certain products or operations in particular markets, including China.”

Annual report 2026A · The company itself

“Building on this strong foundation, we are embracing our role as a healthcare technology leader and evolving our business strategy in three key areas: •Accelerate innovation-driven growth: The combination of our attractive end markets, recent product launches and robust pipeline is expected to enable continued strong revenue growth. We aim to bring inventive and disruptive technology to large healthcare opportunities which enables us to better meet patient needs. Patients around the world deserve access to our life-saving products, and we are driven to use our local presence and scale to increase the adoption of our products and services in markets around the globe.”

Annual report 2026A · The company itself

“•Deliver superior outcomes and better experiences for patients and providers: We listen to our patients and customers to better understand the challenges they face. From the patient journey, to creating agile partnerships that produce novel solutions, to making it easier for our customers to deploy our therapies — what we do is anchored in deep insight, and creates simpler, superior experiences. •Turn data, AI, and automation into action: We are confident in our ability to maximize new technology, AI, and data and analytics to tailor therapies in real-time, facilitating remote monitoring and care delivery that conveniently manages conditions, and creates new standards of care.”

Annual report 2026A · The company itself

“OTHER FACTORS IMPACTING OUR OPERATIONS Research and Development The markets in which we participate are subject to rapid technological advances and innovations. Constant improvement of existing products and introduction of new products is necessary to maintain market leadership. Our research and development (R&D) efforts are directed toward maintaining or achieving technological leadership in the markets we serve to help ensure that patients using our devices and therapies receive the most advanced and effective treatment possible.”

Annual report 2026A · The company itself

“For example, data science, machine learning and AI are all impacting our products and operations and the competitive landscape in which we operate, and the application of these technologies is rapidly evolving at the same time as new laws and regulations governing AI are being developed in jurisdictions around the world.”

Annual report 2026A · The company itself

“Table of Contents CARDIOVASCULAR PORTFOLIO The Cardiovascular Portfolio is made up of the Cardiac Rhythm & Heart Failure, Structural Heart & Aortic, and Coronary & Peripheral Vascular divisions. The primary medical specialists who use our Cardiovascular products include electrophysiologists, implanting cardiologists, heart failure specialists, cardiovascular, cardiothoracic, and vascular surgeons, and interventional cardiologists and radiologists. Cardiac Rhythm & Heart Failure Our Cardiac Rhythm & Heart Failure division includes the following Operating Units: Cardiac Rhythm Management and Cardiac Ablation Solutions. The division develops, manufactures, and markets products for the diagnosis, treatment, and management of heart rhythm disorders and heart failure.”

Annual report 2026A · The company itself

“NEUROSCIENCE PORTFOLIO The Neuroscience Portfolio is made up of the Cranial & Spinal Technologies, Specialty Therapies, and Neuromodulation divisions. The primary medical specialists who use the products of this group include spinal surgeons, neurosurgeons, neurologists, pain management specialists, anesthesiologists, orthopedic surgeons, urologists, urogynecologists, interventional radiologists, and ear, nose, and throat specialists.”

Annual report 2026A · The company itself

“MEDICAL SURGICAL PORTFOLIO The Medical Surgical Portfolio includes the Surgical & Endoscopy and Acute Care & Monitoring divisions. Products and therapies of this group are used primarily by healthcare systems, physicians' offices, ambulatory surgical centers (ASCs), and other alternate site healthcare providers.”

Annual report 2026A · The company itself

“We compete in both the therapeutic and diagnostic medical markets in more than 150 countries throughout the world. These markets are characterized by rapid change resulting from technological advances, innovations and scientific discoveries. Our product lines face a mix of competitors ranging from large companies with multiple business lines to small, specialized manufacturers that offer a limited selection of niche products.”

Annual report 2026A · The company itself

“We manufacture the majority of our products and procure critical third-party services, such as sterilization services, at numerous facilities worldwide.”

Annual report 2026A · The company itself

“In addition, many of our products require sterilization before sale and several of our key products are manufactured or sterilized at a particular facility, with constrained capacity and limited options for alternate sterilization facilities.”

Annual report 2026A · The company itself

“Our Mission is to provide a broad range of therapies to restore patients to fuller, healthier lives, which requires a wide variety of technologies, products and capabilities.”

Annual report 2026A · The company itself

“Our business exposes us to potential product liability risks that are inherent in the design, manufacture, and marketing of medical devices. In addition, many of our products are often used in intensive care settings with seriously ill patients, and some of the medical devices we manufacture and sell are designed to be implanted in the human body for long periods of time or indefinitely.”

Annual report 2026A · The company itself

“Building on this strong foundation, we are embracing our role as a healthcare technology leader and evolving our business strategy in three key areas: •Accelerate innovation-driven growth: The combination of our attractive end markets, recent product launches and robust pipeline is expected to enable continued strong revenue growth. We aim to bring inventive and disruptive technology to large healthcare opportunities which enables us to better meet patient needs. Patients around the world deserve access to our life-saving products, and we are driven to use our local presence and scale to increase the adoption of our products and services in markets around the globe.”

Annual report 2026A · The company itself

“•Deliver superior outcomes and better experiences for patients and providers: We listen to our patients and customers to better understand the challenges they face. From the patient journey, to creating agile partnerships that produce novel solutions, to making it easier for our customers to deploy our therapies — what we do is anchored in deep insight, and creates simpler, superior experiences. •Turn data, AI, and automation into action: We are confident in our ability to maximize new technology, AI, and data and analytics to tailor therapies in real-time, facilitating remote monitoring and care delivery that conveniently manages conditions, and creates new standards of care.”

Annual report 2026A · The company itself

“OTHER FACTORS IMPACTING OUR OPERATIONS Research and Development The markets in which we participate are subject to rapid technological advances and innovations. Constant improvement of existing products and introduction of new products is necessary to maintain market leadership. Our research and development (R&D) efforts are directed toward maintaining or achieving technological leadership in the markets we serve to help ensure that patients using our devices and therapies receive the most advanced and effective treatment possible.”

Annual report 2026A · The company itself

“Further, we have made several public disclosures of objectives and targets relating to product stewardship, inclusion, patient safety and product quality, access and innovation, and climate stewardship, including our ambition to be net carbon neutral in our operations by 2030 and to achieve net zero emissions by 2045. Although we intend to achieve these targets, we may be required to expend significant resources to do so, which could increase our operational costs.”

Annual report 2026A · The company itself

“The Diabetes Business develops, manufactures, and markets products and services for the management of Type 1 and Type 2 diabetes. The primary medical specialists who use and/or prescribe our Diabetes products are endocrinologists and primary care physicians. The principal products and services offered by the Diabetes Business include insulin pumps, continuous glucose monitoring (CGM) systems, and consumables.”

Annual report 2026A · The company itself

“However, due to the U.S. FDA’s manufacturing requirements and those of other regulatory authorities, we may not be able to quickly establish additional or replacement sources for certain components or materials if we experience a sudden or unexpected reduction or interruption in supply and are unable to develop alternative sources.”

Annual report 2026A · The company itself

“To varying degrees, each of these agencies requires us to comply with laws and regulations governing the development, testing, manufacturing, labeling, marketing and distribution of our products, including with respect to product safety and quality, marketing and promotional practices, reimbursement and healthcare fraud and abuse, data privacy, and competition and antitrust compliance.”

Annual report 2026A · The company itself

“Our failure to comply with laws and regulations relating to reimbursement of healthcare goods and services, or changes to such laws, coverage policies, and payment practices, may subject us to penalties and adversely impact demand, our reputation, business, results of operations, financial condition, and cash flows.”

Annual report 2026A · The company itself

“Coverage decisions, utilization management programs (e.g., prior authorization), and variability in payment policies may affect physician adoption, hospital purchasing decisions, procedure volumes, and patient access, even where reimbursement is available. Additionally, differences in coverage, payment rates, or site of service incentives across payors or geographies may result in uneven or delayed adoption of our devices, products, and therapies.”

Annual report 2026A · The company itself

“Our devices, products, and therapies are subject to regulation regarding quality and cost by HHS, including the Centers for Medicare & Medicaid Services (CMS), as well as comparable state and non-U.S. agencies responsible for reimbursement and regulation of health care goods and services, including laws and regulations related to fair competition, kickbacks, false claims, self-referrals and healthcare fraud. Many states have similar laws that apply to reimbursement by state Medicaid and other funded programs as well as in some cases to all payors.”

Annual report 2026A · The company itself

“We also are subject to risks relating to changes in government and private medical reimbursement programs and policies, and changes in legal and regulatory requirements in the U.S. and around the world. Implementation of further legislative or administrative reforms to these reimbursement systems, or adverse decisions relating to coverage of or reimbursement for our products by administrators of these systems, 18 Table of Contents could delay or reduce adoption, limit utilization, or otherwise have an impact on the acceptance of and demand for our products and the prices that our customers are willing to pay for them.”

Annual report 2026A · The company itself

“Most of our customers, and the healthcare providers to whom our customers supply medical devices, rely on third-party payors, including government programs and private health insurance plans, to reimburse some or all of the cost of the procedures in which medical devices are used. The continuing efforts of governmental authorities, insurance companies and other payors of healthcare costs to contain or reduce these costs could lead to patients being unable to obtain approval for coverage and payment from these third-party payors.”

Annual report 2026A · The company itself

“Additionally, government and private payors in the U.S. are increasingly using utilization management programs, particularly prior authorization, which creates administrative burden, reimbursement uncertainty for providers, and patient access delays, leakage, or barriers.”

Annual report 2026A · The company itself

“Government Regulation Our operations and products are subject to extensive regulation by numerous government agencies, including the U.S. FDA, European regulatory authorities such as the Medicines and Healthcare products Regulatory Agency in the United Kingdom, the Health Products Regulatory Authority in the Republic of Ireland and the Federal Institute for Drugs and Medical Devices in Germany, the China National Medical Product Administration (NMPA), and other government agencies inside and outside the U.S.”

Annual report 2026A · The company itself

“Product Approval and Monitoring In many jurisdictions where we do business, including the U.S., the E.U., Japan, and China, our products are subjected to approval and other regulatory requirements regarding performance, safety, and quality. For instance, authorization to commercially distribute a new medical device in the U.S. is generally obtained in one of two primary ways. The first, known as pre-market notification or the 510(k) process, requires us to demonstrate that our medical device is substantially equivalent to a legally marketed medical device.”

Annual report 2026A · The company itself

“We expect this global regulatory environment will continue to evolve, which could impact the cost, the time needed to approve, and ultimately, our ability to maintain existing approvals or obtain future approvals for our products.”

Annual report 2026A · The company itself

“In addition, workforce reductions and agency reorganization at the U.S. FDA have, and could continue to have, an impact on product approval timelines and other types of agency oversight.”

Annual report 2026A · The company itself

“Our medical devices and technologies, as well as our business activities, are subject to a complex set of regulations and rigorous enforcement, including by the U.S. FDA, U.S. Department of Justice, Health and Human Services Office of the Inspector General, and numerous other federal, state, and non-U.S. governmental authorities in the countries where we operate.”

Annual report 2026A · The company itself

“FDA and other applicable non-U.S. government agency regulations. For instance, many of our facilities and procedures, and those of our suppliers, contract manufacturers, and other third-party vendors, are subject to periodic inspections by the U.S.”

Annual report 2026A · The company itself

“In the current environment of managed care, consolidation among healthcare providers, increased competition, site of service shifts, government efforts to control healthcare costs, and competitively priced product offerings are essential to our success.”

Annual report 2026A · The company itself

“Implementation of legislative or regulatory reforms to reimbursement systems, or adverse decisions relating to our products by administrators of these systems in coverage or reimbursement, could significantly reduce reimbursement or result in the denial of coverage, which could have an impact on the acceptance of and demand for our products and the prices that our customers are willing to pay for them.”

Annual report 2026A · The company itself

“We have had, and may continue to have, periods when prices for certain of our goods and services decrease due to pricing pressure from managed care organizations and other third-party payors on our customers; increased market power of our customers as the healthcare industry consolidates; periodic variation in timing, volume, and pricing associated with customer purchasing patterns and stocking dynamics; and increased competition among medical engineering and manufacturing services providers.”

Annual report 2026A · The company itself

“In addition, the movement of procedures to ASCs, or other lower-cost sites of care, could also create downward pricing pressure. If we must reduce our prices because of industry consolidation or site of service shifts, or if we lose customers as a result of consolidation, growth in ASCs, or site of service shifts, our business, results of operations, financial condition, and cash flows could be adversely affected.”

Annual report 2026A · The company itself

“For example, managed care organizations have successfully negotiated volume discounts for pharmaceuticals, and GPOs and IDNs have also concentrated purchasing decisions for some customers, which has led to downward pricing pressure for medical device companies, including us.”

Annual report 2026A · The company itself

“Data Privacy and Security Laws and Regulations As a business with a significant global footprint, compliance with evolving regulations and standards in data privacy and cybersecurity has resulted, and may continue to result, in increased costs, new compliance challenges, and the threat of increased regulatory enforcement activity. Our business relies on the secure electronic transmission, storage and hosting of sensitive information, including personal information, protected health information, financial information, intellectual property and other sensitive information related to our products and therapies, customers, patients, and workforce.”

Annual report 2026A · The company itself

“We rely on the proper function, security and availability of our information technology systems and data, as well as those of third parties throughout our global supply chain and our customer and payor base, to operate our business, and a breach, cyber-attack or other disruption to these systems or data could materially and adversely affect our business, results of operations, financial condition, cash flows, reputation or competitive position.”

Annual report 2026A · The company itself

“The techniques used to obtain unauthorized access to, or disrupt, information technology systems continue to evolve and may be further amplified by the use of AI and other emerging technologies by malicious actors. Like all organizations, we routinely experience attempted interference with the integrity of, and interruptions in, our technology systems via events such as cyber-attacks, malicious intrusions, or other breakdowns. The consequences of such an event could mean data breaches, interference with the integrity of our products and data, the compromising of our intellectual property or other proprietary information, operational disruptions, the need to implement manual processes or other temporary workarounds, or other significant disruptions.”

Annual report 2026A · The company itself

“Furthermore, we rely on third-party vendors to supply and/or support certain aspects of our information technology systems and resulting products, and customers and payors use information technology systems to process payments relating to our products and services. These third-party systems could also become vulnerable to cyber-attack, malicious intrusions, breakdowns, interference, or other significant disruptions, and may contain defects in design or manufacture or other problems that could result in system disruption or compromise the information security of our own systems. Cybersecurity incidents affecting third-party service providers, or systems on which we rely, may adversely impact our operations even if our own systems are not directly compromised.”

Annual report 2026A · The company itself

“Government‑driven pricing and procurement mechanisms, including national and provincial tender pricing programs such as volume‑based procurement initiatives in China, may require significant price concessions and constrain our ability to compete on factors other than price.”

Annual report 2026A · The company itself

“Trade Regulations The movement of products, services, technology, know-how, and investment across borders subjects us to extensive trade laws and regulations, including tariff regulations adopted by different countries or trading zones. These laws and regulations govern, among other things, our import, export and other international trade activities.”

Annual report 2026A · The company itself

“Changes in the international trade policy of the U.S. and other countries, including increased trade restrictions or tariffs, have the potential to adversely impact Medtronic. The ongoing global economic competition and trade tensions between the U.S. and China, as well as increased tariffs between the U.S. and other trading partners, including Mexico, Canada, the E.U. and other countries and regions in which we do business, impose significant costs and present a risk to Medtronic.”

Annual report 2026A · The company itself

“Trade, export control, and other regulatory measures are increasingly targeted toward specific technologies and capabilities, such as software, digital health solutions, and AI-enabled tools, which could restrict our ability to develop, manufacture, deploy, service, or support certain products or operations in particular markets, including China.”

Annual report 2026A · The company itself

“The Medical Device Regulation was published by the E.U. in 2017, and it imposes significant additional pre-market and post-market requirements (EU MDR). The regulation provided an implementation period and became effective on May 26, 2021. The European Commission extended the implementation period to the end of 2027 for high-risk devices and to the end of 2028 for medium and low risk devices.”

Annual report 2026A · The company itself

“There have been and continue to be actions and proposals by several governments, regulators and third-party payors globally, including the U.S. federal and state governments and the government in China, to control healthcare costs and, more generally, to reform healthcare systems. Certain of these actions and proposals, among other things, limit the prices we are able to charge for our products or the amounts of reimbursement available for our products, increase the importance of our ability to compete on cost and outcomes, and could limit the acceptance and availability of our products.”

Annual report 2026A · The company itself

“Other disruptions in the manufacturing process or product sales, trade and fulfillment systems for any reason, including infrastructure, information and equipment malfunction, including due to cyber attacks, failure to follow specific protocols and procedures, supplier or Company facility shut-downs, defective raw materials, labor shortages, natural disasters such as hurricanes, tornadoes, earthquakes, or wildfires, property damage or facility closures from riots or public protests, and other environmental factors and the impact of epidemics, pandemics, or other public health crises, and actions by businesses, communities and governments in response, could lead to launch delays, product shortages, unanticipated costs, lost revenues and damage to our reputation.”

Annual report 2026A · The company itself

“Our global operations and interactions with healthcare systems, providers and patients around the world expose us to risks associated with public health crises, including epidemics and pandemics. Public health crises may continue to have an adverse impact on certain aspects of 16 Table of Contents our Company and business, including the demand for and supply of certain of our products, operations, supply chains and distribution systems, and our ability to generate cash flow.”

Annual report 2026A · The company itself

“We have also recently experienced, and may continue to experience, rising costs due to inflation. If the prices for our goods and services change for any reason or inflation continues to rise, we may be unable to sufficiently reduce our expenses or offset rising costs through increased prices to customers.”

Annual report 2026A · The company itself

“Some governments impose economic sanctions and other trade restrictions against certain countries, persons or entities.”

Annual report 2026A · The company itself

“Because of the predominance of government-administered healthcare systems in many jurisdictions around the world, many of our customer relationships outside of the U.S. are with governmental entities and are therefore potentially subject to such laws.”

Annual report 2026A · The company itself

“From time to time, certain of our subsidiaries have limited business dealings in countries subject to comprehensive sanctions, including Iran, Syria, Cuba, and the region of Crimea, as well as in other jurisdictions subject to significant sanctions or export controls, such as Russia and Belarus. Certain of our subsidiaries sell medical devices, and may provide related services, to distributors and other purchasing bodies in such countries or regions.”

Annual report 2026A · The company itself

“The Russia-Ukraine conflict and resulting sanctions and export restrictions are creating barriers to doing business in Russia and Belarus and adversely impacting global supply chains.”

Annual report 2026A · The company itself

“In addition, military operations in the Middle East have disrupted maritime traffic in and around the Strait of Hormuz and have driven higher energy costs, which may strain global supply chains and adversely affect our business, results of operations, financial condition, and cash flows. Conflict in Israel and in the Middle East region generally may also disrupt our operations and could adversely impact global supply chains and our business, results of operations, financial condition, and cash flows.”

Annual report 2026A · The company itself

“Additionally, many regulatory agencies are imposing new and evolving regulatory requirements related to the safe use of chemicals, including ethylene oxides (EtOs) and polyfluoroalkyl substances (PFAS), and their potential impact on health and the environment, which also may impact supply constraints.”

Annual report 2026A · The company itself

“We are subject to environmental, health, and safety laws, and regulations concerning, among other things, the generation, handling, transportation, and disposal of hazardous substances or wastes, the remediation of hazardous substances or materials at various sites, and emissions or discharges into the land, air or water. We are further subject to numerous laws and regulations concerning, among other things, chemical constituents in medical products and end-of-life disposal and take-back programs for medical devices. Our operations and those of 22 Table of Contents certain third-party suppliers involve the use of substances subject to these laws and regulations, primarily those used in manufacturing and sterilization processes. If we or our suppliers violate these environmental laws and regulations, facilities could be shut down and violators could be fined, subject to sanctions, or we or our suppliers could be subject to civil litigation and penalties or costs associated with remediation.”

Annual report 2026A · The company itself

“Our business is also affected by data privacy, security and digital health laws, such as the European Health Data Space (EHDS) regulation, as well as government payor cost containment initiatives, and environmental health and safety laws and regulations.”

Annual report 2026A · The company itself

“There is continued focus from our stakeholders, as well as regulatory authorities in the U.S., E.U. and other global jurisdictions in which we operate, on sustainability practices and disclosure. If we do not succeed in meeting or are perceived as not meeting goals and objectives relating to environmental stewardship, inclusion initiatives, supply chain practices, good corporate governance, workplace conduct and support for local communities, or if we do not effectively respond to new or revised legal, regulatory or reporting requirements concerning climate change, inclusion, or other sustainability concerns, we may be subject to regulatory fines and penalties, including potential loss of eligibility as a U.S. government contractor, our reputation or the reputation of our brands may suffer, we may be unable to attract and retain top talent, and our stock price may be negatively affected.”

Annual report 2026A · The company itself

“We believe our ability to compete depends upon many factors both within and beyond our control, including: •product performance and reliability, •product technology and innovation, •product quality and safety, •breadth of product lines, •product support services, •supplier and supply availability and performance, •customer support, •cost-effectiveness and price, •reimbursement approval from healthcare insurance providers, and •changes to the regulatory environment.”

Annual report 2026A · The company itself

“We have debt obligations that create risk. We are required to use a portion of our operating cash flow to pay interest or principal on our outstanding indebtedness instead of for other corporate purposes, including funding future expansion of our business.”

Annual report 2026A · The company itself

“While we have no manufacturing, distribution or direct material suppliers in the region, we continue to closely monitor the potential raw material/sub-tier supplier impact in both Russia and Ukraine including materials like palladium and neon, which are both dependent on Russia supply.”

Annual report 2026A · The company itself

“More broadly, certain critical materials and components used in our products or manufacturing processes may be sourced from, processed in, or subject to regulatory oversight in a limited number of jurisdictions, increasing our exposure to supply disruptions, price volatility, or regulatory leverage arising from geopolitical tensions.”

Annual report 2026A · The company itself

“In addition, as a result of the release and availability of AI technologies, including generative AI platforms, we have seen a global trend toward more comprehensive regulation of AI designed to ensure the ethical use, security, and privacy of AI and create standards for transparency, accountability, and fairness, including the EU AI Act, which may impact our business.”

Annual report 2026A · The company itself

“If these conditions were to recur or worsen, we may experience reduced demand for a number of our products. We also could experience reduced sales and profits due to delayed payments or the insolvency of healthcare professionals, hospitals and other customers, suppliers and vendors who experience liquidity issues, including as a result of cybersecurity incidents impacting private and government health insurance payors.”

Annual report 2026A · The company itself

“Other disruptions in the manufacturing process or product sales, trade and fulfillment systems for any reason, including infrastructure, information and equipment malfunction, including due to cyber attacks, failure to follow specific protocols and procedures, supplier or Company facility shut-downs, defective raw materials, labor shortages, natural disasters such as hurricanes, tornadoes, earthquakes, or wildfires, property damage or facility closures from riots or public protests, and other environmental factors and the impact of epidemics, pandemics, or other public health crises, and actions by businesses, communities and governments in response, could lead to launch delays, product shortages, unanticipated costs, lost revenues and damage to our reputation.”

Annual report 2026A · The company itself

“Other disruptions in the manufacturing process or product sales, trade and fulfillment systems for any reason, including infrastructure, information and equipment malfunction, including due to cyber attacks, failure to follow specific protocols and procedures, supplier or Company facility shut-downs, defective raw materials, labor shortages, natural disasters such as hurricanes, tornadoes, earthquakes, or wildfires, property damage or facility closures from riots or public protests, and other environmental factors and the impact of epidemics, pandemics, or other public health crises, and actions by businesses, communities and governments in response, could lead to launch delays, product shortages, unanticipated costs, lost revenues and damage to our reputation.”

Annual report 2026A · The company itself

“The Russia-Ukraine conflict and resulting sanctions and export restrictions are creating barriers to doing business in Russia and Belarus and adversely impacting global supply chains.”

Annual report 2026A · The company itself

“We use resins, other petroleum-based materials and pulp as raw materials in some of our products, and the prices of oil and gas also significantly affect our costs for freight and utilities.”

Annual report 2026A · The company itself

“We use resins, other petroleum-based materials and pulp as raw materials in some of our products, and the prices of oil and gas also significantly affect our costs for freight and utilities.”

Annual report 2026A · The company itself

“Development by other companies of new or improved products, processes, technologies, or the introduction of reprocessed products or competitive devices when our proprietary products lose their patent protection may make our existing or planned products less competitive.”

Annual report 2026A · The company itself

“We have generally been able to obtain adequate supplies of such raw materials, components and services, although global shortages of certain components such as semiconductors and resins have previously caused, and may in the future cause, disruptions to our product manufacturing supply chain.”

Annual report 2026A · The company itself

“We have generally been able to obtain adequate supplies of such raw materials, components and services, although global shortages of certain components such as semiconductors and resins have previously caused, and may in the future cause, disruptions to our product manufacturing supply chain.”

Annual report 2026A · The company itself

“Government‑driven pricing and procurement mechanisms, including national and provincial tender pricing programs such as volume‑based procurement initiatives in China, may require significant price concessions and constrain our ability to compete on factors other than price.”

Annual report 2026A · The company itself

“We also are subject to various other country-specific requirements around the world, such as the General Data Protection Regulation (GDPR) in the European Economic Area, the United Kingdom’s privacy laws, and China's Personal Information Protection Law (PIPL).”

Annual report 2026A · The company itself

“For example, business in China comprises approximately six percent of our total revenues.”

Annual report 2026A · The company itself

“China, which comprises approximately six percent of our total revenue, and the U.S., could impose other types of restrictions such as limitations on government procurement or technology export restrictions, which could affect Medtronic’s access to significant markets.”

Annual report 2026A · The company itself

“The Company’s largest manufacturing facilities are located in the U.S., Mexico, Puerto Rico, China, Ireland, Dominican Republic, Switzerland, Italy, and France.”

Annual report 2026A · The company itself

“For example, business in China comprises approximately six percent of our total revenues.”

Annual report 2026A · The company itself

“We develop, manufacture, distribute and sell our products globally. We intend to continue to expand our operations and to pursue growth opportunities outside the U.S., especially in emerging markets.”

Annual report 2026A · The company itself

“The Company’s largest manufacturing facilities are located in the U.S., Mexico, Puerto Rico, China, Ireland, Dominican Republic, Switzerland, Italy, and France.”

Annual report 2026A · The company itself

“We also are subject to various other country-specific requirements around the world, such as the General Data Protection Regulation (GDPR) in the European Economic Area, the United Kingdom’s privacy laws, and China's Personal Information Protection Law (PIPL).”

Annual report 2026A · The company itself

“The Company’s largest manufacturing facilities are located in the U.S., Mexico, Puerto Rico, China, Ireland, Dominican Republic, Switzerland, Italy, and France.”

Annual report 2026A · The company itself

“We develop, manufacture, distribute and sell our products globally. We intend to continue to expand our operations and to pursue growth opportunities outside the U.S., especially in emerging markets.”

Annual report 2026A · The company itself

“To the extent that these conflicts result in increased spending by governments on defense and diversion of resources from healthcare spending, our business may also be adversely affected.”

Annual report 2026A · The company itself

“Properties Medtronic's principal executive office is located in Ireland and is owned by the Company, while its main operational offices are located in the Minneapolis, Minnesota metropolitan area and are owned by the Company.”

Annual report 2026A · The company itself

“In addition, strikes or other work stoppages by healthcare professionals and staff have in the past and may in the future cause reduced demand for our products.”

Annual report 2026A · The company itself