Medical Device and Technology Regulatory

Bringing a medical device to market means tackling financing, patents, approvals, manufacturing, and distribution. We see the whole picture – helping you accelerate entry, innovate through change, and protect your advantage.

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After your product debuts, the challenges continue throughout its life cycle, from running compliance programs to responding to enforcement actions. And if you’re operating globally, the last thing you want to do is to oversee a patchwork of different firms in different locations.

Hogan Lovells has you covered. We operate on a global scale, coordinating among lawyers in offices in all of the world’s major medical markets to sequence and streamline regulatory approvals. We accelerate market entry – moving faster through fragmented and overlapping cross-border regulation. In the U.S., we’ve been helping companies get new products approved by the Food and Drug Administration (FDA) since the Medical Device Amendments of 1976 was signed into law.

We have a deeper understanding of commercial dynamics and legislative direction, enabling our clients to leverage regulation for strategic advantage. This means we can help to expedite FDA approval and CE marking and design programs to successfully launch products around the world, while ensuring continuing compliance. We can also help develop reimbursement strategies to ensure your hard work leads to business success, and we can build the necessary infrastructure for a transaction or initial public offering when the time comes.

Unlike our competitors, we have a dedicated team of over 30 experienced medical device lawyers, many of whom have worked for regulatory agencies and in private industry, and have backgrounds in biostatistics, medicine, biomedical engineering, material science, pharmacy and genetics, among other disciplines. We bring technical insight and deep connections to help you shape policy, make better decisions, and stay ahead of the market.

From inception and approval to debut and product maturity, we provide guidance that takes into account the complex considerations where business and compliance meet – helping you adapt and thrive through change.

Advertising and Promotion Compliance

In Vitro Diagnostics

Premarket Review

State Medical Device Distribution & Manufacturer Licensing

Quality management systems and inspections

Recalls, corrections, and removals

Import and export

Intellectual property

Combination products

Financing, distribution and other agreements

Cell, tissue, and gene therapies

Good clinical practice compliance

Digital health

Artificial Intelligence

Emergency Use Authorization and pandemic related product

Our medical device lawyers help companies understand the regulators’ requirements for developing and manufacturing their medical devices in accordance with applicable quality management system (QMS) standards; conducting product recalls (or determining whether one is needed); reporting adverse events; and disseminating labeling, advertisements, and other promotional materials.

Our lawyers help companies balance legal compliance with their business objectives helping them to navigate the current environment, highlighted by evolving U.S. Food and Drug Administration (FDA) and EU Member States laws. From regulations and policies governing medical device labeling, advertising and promotion; to the ever-expanding types of media platforms available to companies to promote their devices, the Internet to social media; and ongoing, steady government enforcement.

Our lawyers, including technically trained consultants and scientists, have a broad range of experience in the field of in vitro diagnostic (IVD) products at all stages of development and for a variety potential uses. Due to the mix of our professional staff, we are able to offer both legal and regulatory services to pharmaceutical, life sciences, biological, and medical device/ diagnostic manufacturers and health care service providers.

Our premarket review practice focuses on providing strategic advice from the earliest stages in the product development cycle in order to optimize the regulatory pathway. Leveraging the technical background of our lawyers and regulatory science professionals, we provide comprehensive regulatory assistance during all phases of the Food and Drug Administration (FDA) clearance or approval process.

Medical Device manufacturers who distribute prescription and over-the-counter (OTC) devices are subject to a complex web of state licensing requirements that can attach to their manufacturing and/or distribution activity. Further, many medical device manufacturers take advantage of the services of third party logistics (3PL) providers who are also subject to separate state licensing requirements; all of which are separate from the business licenses that companies need to obtain conduct business in the state.

Our medical device lawyers and regulatory science professionals have extensive experience in designing and implementing robust quality management systems for medical device manufacturers; auditing companies’ quality management systems; and preparing companies for U.S. Food and Drug Administration (FDA), international regulatory inspections, other third party inspections, and EU notified body audits. This means that we can help you implement quality systems that are designed to improve your products and processes; recognize opportunities for improvement; and take remedial action as a result of audit and inspectional findings.

A product recall is always an unplanned and unexpected event. The decision as to whether or not a field action is warranted is one of the most difficult decisions a medical device company can be faced with. Our experienced team helps clients assess field action decisions, develop compliant strategies, and manage global recalls – including high-risk Class I events. With a presence across the U.S., EU, Asia, and South America, we coordinate cross-border efforts to align with evolving regulatory expectations. We guide companies through FDA and international notifications, liability planning, communication strategies, and device modifications.

Companies that import medical devices to and from the U.S. have faced increasing difficulty with the import process in recent years because of tightened requirements, due primarily to the increase in the number of products and subassemblies manufactured abroad, as well as terrorism concerns. For example, the U.S. Food and Drug Administration (FDA) now requires pre-clearance of imports and accountability of products at every point in the supply chain prior to entry. Additionally, FDA is inspecting more foreign facilities and is imposing limitations on a firms’ ability to import as a negative consequence of unfavorable inspections.

Our patent lawyers believe that medical devices are often best protected through an interdisciplinary approach that takes into account not only patent law, but also regulatory requirements, health care- related revenue models, and health care policies, such as those involving privacy and reimbursement.

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As medical technology continually advances, many products are being developed that are not simply new drugs, biological products, or devices, but rather are a combination of these products. Others are single entity products where regulatory responsibility is unclear because the product may have more than one mode of action.

As in every industry, our medical device clients frequently seek private and public investment. They also engage in mergers and acquisitions and corporate restructurings. When they do, we frequently serve as special U.S. Food and Drug Administration’s (FDA) and EU counsel to advise or provide an opinion. We are also retained by underwriters and investors for this purpose.

Medical therapies at the frontiers of science and medicine, such as those using stem cells, placental tissue, and viral vectors to correct defective genes, pose unique challenges. One critical issue is how they will be regulated, both within and outside the U.S. We have a cross-disciplinary, international working group with extensive experience advising clients on regulatory pathways for a wide range of cell, tissue, and gene therapies. Many human cell or tissue products (HCT/Ps) can be marketed without prior FDA approval, while some are much more highly regulated in the United States.

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We have established industry-leading strength in advising companies on good clinical practice (GCP) compliance in the medical device and pharmaceutical and biotechnology sectors. Our medical device and pharmaceutical and biotechnology groups also have well-established relationships with a large network of outside GCP consultants and auditors, many of whom have substantial U.S. Food and Drug Administration (FDA) and industry experience.

The intersection between tech and health care brings enormous business potential, as well as unique legal and regulatory issues. From mobile medical apps and standalone software as a medical device to wearable sensors and digital therapeutics, our digital health team has extensive experience counseling clients on the U.S. Food and Drug Administration (FDA) and EU implications for new technology.

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From smartphones to self-driving cars, artificial intelligence (AI) influences nearly every aspect of modern life. Health care is no exception. Use of artificial intelligence systems promises better health care management for patients and faster, more accurate diagnoses for doctors. Companies pursuing AI technologies must realize that while the health care industry is embracing this technology, the regulatory landscape is still finding its footing.

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Disruptions to operations caused by the COVID-19 pandemic are unprecedented, creating the ultimate stress test for global businesses. Our team has taken on over 200 matters, ranging from attaining U.S. Food and Drug Administration (FDA) Emergency Use Authorizations (EUAs) for critical medical devices and testing kits, to advising on legal risks of producing various types of personal protective equipment (PPE) and importing devices – such as ventilators from China – for use in the U.S. and around the world.

Hear from our clients and industry leaders

The Hogan Lovells team provides practical and risk-based advice as well as flexibility and efficiency."

Chambers & Partners, USA Guide, 2025

The team provide dependable excellence, deep subject matter expertise and an ability to be thought partners. They have earned a superior regulation and the trust of peers in the industry."

Chambers & Partners, USA Guide, 2025

Key contacts

Randy J. Prebula

Partner

Randy J. Prebula

Partner

Washington, D.C.

Janice M. Hogan

Partner

Janice M. Hogan

Partner

Philadelphia, Washington, D.C.

Jonathan S. Kahan

Partner

Jonathan S. Kahan

Partner

Washington, D.C.

Michael S. Heyl

Partner

Michael S. Heyl

Partner

Washington, D.C.

Jodi Scott

Partner

Jodi Scott

Partner

Denver

Meet the Medical Device and Technology Regulatory team

Representative experience

Assisting multiple clients regarding EUA submissions for COVID-19 diagnostic tests, treatments, and surgical masks.

Advising numerous non-traditional life sciences and device companies on the requirements and logistics of producing critical need supplies.

Advised Vayu Global Health Innovations in obtaining an EUA from FDA that allowed its bubble CPAP device to be immediately distributed to hospitals to help alleviate the ventilator shortage due to COVID-19.

Teamed up with regulatory consultant Wanda Henry Co. to advise Sansure Biotech, Inc. in its FDA EUA for a molecular diagnostic test kit for COVID-19.

Advising Ford Motor Company in its collaboration with GE Healthcare to help reinforce the Strategic National Stockpile and to support the treatment of coronavirus patients.

Advised the Kraft Group/New England Patriots to obtain the necessary government approvals to pick up 1.3 million N95 masks from Shenzhen, China, and deliver them to the Commonwealth of Massachusetts.

Developed an innovative strategy for interacting with FDA for Viz.ai to gain a quick De Novo clearance for a novel Computer-Aided Triage and Notification Platform to identify LVO strokes in CTA imaging.

Successfully assisted IDx LLC to achieve De Novo reclassification from the FDA for the ground-breaking AI-based device IDx-DR, which autonomously analyzes images of the retina for signs of diabetic retinopathy.

Assisted a client in developing a recall strategy that involved all products produced by the company, which was classified as a Class I recall.

Help develop clinical and regulatory strategies for a number of clients that are developing biomarkers and molecular diagnostics that would be companion assays to drugs.

Conducted numerous Quality System Regulation (QSR and ISO 1345) audits domestically and internationally to help companies make their processes more robust and to prepare them for inspections and audits.

Advocated the FDA’s reclassification of a novel imaging device, tissue culture media products for ex vivo growth of human cells, and a variety of in vitro diagnostic test systems, avoiding the need for a PMA approval.

Assisted CSD Labs in obtaining 510(k) clearance of eMurmur, an innovative, AI-based murmur detection software.

Conducted internal investigations and compliance audits to ensure that promotional activities did not violate the Federal Food, Drug, and Cosmetic Act.

Assisted clients with novel devices featuring AI and machine learning algorithms in developing and gaining FDA alignment on creative regulatory strategies to bring these products to market quickly and efficiently.

Worked on pre-market submissions for IVDs in the medical device and biologics areas and on IND applications for imaging agents.

Assisting several medical devices clients in preparing distribution, importer, and authorized representative agreements reflecting the obligations of the EU MDR.

Awards and recognitions

Tier 2 for EU Regulatory: Pharma, Medical Devices and Biotech

Legal 500 EMEA

2025

Band 1 for Life Sciences

Chambers & Partners, Global Guide

2025

Band 1 for Life Sciences: Regulatory/Compliance

Chambers & Partners, Global Guide

2025

Tier 1 for Life Sciences and Healthcare: Foreign Firms

Legal 500 US

2025

Resources

Video

MedTech Frontiers

Medical devices and Tecnology webinar series.

Watch the series

Our thinking

Talking the Cure Podcast

Our team is always thinking about how to foresee and conquer the most significant industry issues facing our clients. In 2020, we launched the podcast "Talking the Cure" where we cover cutting-edge topics such as AI, digital health, diversity in clinical trials, supply chains, the Inflation Reduction Act, and more.

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Guide

Life Sciences and Health Care Horizon Guide

Our Horizons edition brings together insights from across our global Life Sciences and Health Care team, exploring the issues and developments shaping the future of the industry.

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Digital Client Solutions

AI Hub

Our interactive AI Hub serves as a central resource covering the latest trends and developments. Explore the hub to find recent thought leadership, navigate new laws and regulations, and to get in touch with our AI market-leaders.

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Digital Client Solutions

Medical Device HIPAA Compliance Toolkit

We simplify HIPAA compliance and provide documentation to help your company implement a HIPAA compliance program.

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Event

AI Health Law & Policy Summit

Hogan Lovells hosted our annual AI Health Law & Policy Summit on 1 - 2 May 2024 in our Washington, D.C. office. In this informative and interactive program, our thought leaders and industry guests addressed a variety of topics including new and emerging health care AI policies and regulatory considerations, implications for ethics and consumer safety, developments in the EU, and more.

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