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New Regulations Medical Devices

Hogan Lovells

FDA finalizes cyber device “select updates” guidance, potentially affecting substantial equivalence findings for 510(k)s

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The U.S. Food and Drug Administration (FDA) recently finalized its March 2024 select updates to its guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (“Premarket...more

Quarles & Brady LLP

Puerto Rico Repeals Special Authorization Requirement for Nonresident Manufacturers and Distributors

Quarles & Brady LLP on

In July 2022, the agency formerly known as the Puerto Rico Auxiliary Secretariat for Regulation and Accreditation of Health Facilities (SARAFS), now the Auxiliary Secretariat for the Regulation of Public Health (SARSP),...more

Hogan Lovells

Be vigilant: new post-market surveillance requirements for medical devices in Great Britain take effect

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The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (PMSR), which were passed into law on 22 October 2024, came into force today (16 June 2025), amending the UK’s Medical...more

Jones Day

Vital Signs: Digital Health Law Update | Spring 2025

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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more

Gardner Law

Staying Prepared Amid FDA Changes

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Despite recent staffing reductions and leadership transitions at the FDA, pharmaceutical and medical device manufacturers should not interpret these changes as a signal of reduced regulatory enforcement. On the contrary, the...more

Hogan Lovells

New ministerial guidance letter: a vague framework that contradicts three of the CEPS's positions while leaving it alone in charge...

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The new ministerial guidance letter (‘LOM’) intended to guide the Economic Committee for Health Products (‘CEPS’) on the pricing strategy for pharmaceutical products and medical devices has been signed and published on 5 May...more

Alston & Bird

Health Care Week in Review | White House Issues Executive Orders on Biosecurity and Domestic Drug Production; House Committee...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

ArentFox Schiff

What Life Sciences Companies Need to Know in 2025

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Key Insights for Pharma Manufacturers Regarding the AKS - In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General...more

Clark Hill PLC

Administrative Law Report - April 2025, Vol. 6

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Welcome to your monthly rundown of all things administrative law, where we highlight all the happenings you may have missed. ...more

A&O Shearman

New CJEU ruling on the borderline between medicinal products and medical devices: Key takeaways

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The boundary between medicinal products and medical devices remains a recurring issue for companies developing or marketing borderline products and courts, which has already been the subject of numerous decisions. Recently,...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Second Quarter of 2025 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 10, December 2024

Happy Holidays and welcome to our year-end issue of Decoded. We hope you enjoyed reading our technology law insights e-newsletter this year. We are already planning for 2025. ...more

McDermott Will & Emery

Key Features of the New EU Product Liability Directive: Increased Potential for Litigation in the Technology, Pharmaceutical and...

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On October 10, 2024, the Council of the European Union adopted the new EU Directive on Liability for Defective Products (New PLD), repealing Directive 85/374/EEC (PLD), adopted in 1985....more

Stikeman Elliott LLP

Regulatory Amendments Impacting Drug and Medical Device Recalls Coming Into Force

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On December 17, 2024, recent amendments to the Food and Drug Regulations (FDR) and the Medical Devices Regulations (MDR) relating to the recall of drugs and medical devices will come into force....more

Burr & Forman

Proposed Revisions to Title II of the ADA Impacting Healthcare Facilities

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The Department of Justice recently published a notice of proposed rulemaking applicable to healthcare entities covered under Title II of the Americans with Disabilities Act that relates to accessibility to medical diagnostic...more

Knobbe Martens

New Ethylene Oxide Regulations may Raise Cost of Sterilization

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Last week, the Environmental Protection Agency (EPA) announced new regulations to reduce ethylene oxide emissions. According to the EPA’s press release, the new regulations are “the strongest measures in U.S. history to...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 1, January 2024

The Current Status of Privacy Laws Across the United States - Unlike the General Data Protection Regulation (GDPR) in the European Union (EU), the United States does not have a nationwide comprehensive data privacy law....more

Foley & Lardner LLP

Regulation of Digital Health Products by FDA

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Industry insiders can all agree that the U.S. Food & Drug Administration (FDA) regulates the use of medical devices. Most insiders agree that a medical device is any instrument, apparatus, implement, machine, contrivance,...more

Hogan Lovells

Medical device advertising in Spain

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The Ministry of Health takes steps to update the regulatory framework applicable to the advertising of medical devices. The Spanish Health Act gives the authorities control over health advertising. In particular, Article 102...more

King & Spalding

Medical Devices in the EU: MDD Certificates Remain Valid - the EU Extends Transition Periods for MDR Compliance, and Sell-Off...

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Today, on Monday, March 20, 2023, Regulation (EU) 2023/607 of the European Parliament and of the Council of March 15, 2023, amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards transitional provisions for certain...more

Goldberg Segalla

EPA Renews Push for New ‘EtO’ Regulations and Outreach

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Following a study of 100 commercial sterilizer facilities, the U.S. Environmental Protection Agency announced on August 3 it would takes steps to inform communities throughout the country about the risks posed by ethylene...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 8th - 10th, Anaheim, CA

Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more

Hogan Lovells

European Commission adopts a Regulation on electronic instructions for use for MDR-covered devices

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The European Commission adopted Implementing Regulation (EU) 2021/2226 which establishes the conditions under which instructions for use of certain medical devices subject to the Medical Devices Regulation can be provided in...more

Latham & Watkins LLP

UK’s MHRA Seeks “Bold New Regulatory Regime” for Medical Devices and Diagnostics

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The agency’s consultation on the post-Brexit regulatory framework for medical devices and diagnostics aims to support innovation and sustainability, among other goals. A 10-week consultation launched by the UK’s Medicines...more

McDermott Will & Emery

Brexit and COVID-19: Changes to the Regulation of Medicines

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The combination of the Coronavirus (COVID-19) pandemic and the imminent end of the Brexit transition period means a fast-changing regulatory environment for medicines. On 16 October 2020, the UK Government made changes to...more

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