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Medical Devices › Risk Management › Reporting Requirements

Hogan Lovells

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

Hogan Lovells on

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

Hogan Lovells

MHRA publishes guidance on to new UK medical device post-market surveillance requirements

Hogan Lovells on

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a suite of guidance specifically designed to help medical device manufacturers understand and prepare for the new post-market surveillance (“PMS”)...more

Hogan Lovells

FDA warns of “important” clinical trial protocol deviations

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for sponsors, investigators, and...more

McDermott+

FDA Issues Final Guidance on Predetermined Change Control Plans for AI-Enabled Devices

McDermott+ on

On December 3, 2024, the US Food and Drug Administration (FDA) published final guidance titled, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software...more

Gardner Law

Transatlantic Legal-Regulatory Update: Live from the Heart of Silicon Valley

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US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more

King & Spalding

FDA FY 2021 Budget Foretells Medical Device Cybersecurity Reform

King & Spalding on

Increased premarket submission and post-market reporting requirements potentially on the horizon for high-tech devices. The Food and Drug Administration’s (“FDA’s”) budget proposal for FY2021 telegraphs FDA’s plan to seek new...more

Pillsbury Winthrop Shaw Pittman LLP

A Lifelong Commitment: FDA Releases Postmarket Guidance on Cybersecurity Risk Management for Medical Device Manufacturers

Pillsbury Winthrop Shaw Pittman LLP on

On January 22, 2016, the Food and Drug Administration (FDA) issued draft guidance titled “Postmarket Management of Cybersecurity in Medical Devices,” setting forth proposed recommendations for the medical device industry as...more

Troutman Pepper

FDA's Expanding Views on Cybersecurity and Medical Devices: Draft Guidance on Postmarket Management of Cybersecurity

Troutman Pepper on

Medical device manufacturers need to consider cybersecurity controls in all aspects of the product development process, from conception through commercialization. In response to concerns about increased cybersecurity...more

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