Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 236: Advocating for Accessible Diagnoses with Sydney Severance of Operation Upright
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 233: Prioritizing Women’s Health Through Innovation with Lindsey Calcutt of Incora Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 228: Designing & Manufacturing Auto-Injectors with Kimberlee Steele of SHL Medical
Building a Business at the Intersection of Neurodata and Innovation With Rob Cooley
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 209: North Carolina’s Life Sciences Industry with Laura Gunter of NCLifeSci
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 208: Extended Reality Technology and the ThinkReality Headset with Mattney Beck of Lenovo
AI in the Operating Room: Liability Issues for Device Makers — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
Meet Meaghan Luster: Patent Litigation Associate at Wolf Greenfield
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 177: Brain Health and Research with Dr. Fridriksson, Neuroscientist, Professor, & Vice President of Research at the Universit
Transparency and the Open Payments Program
Medical Device Legal News with Sam Bernstein: Episode 19
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
Health + Tech - Improving Cancer Care With Digital Health Tools
Medical Device Legal News with Sam Bernstein: Episode 14
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its responses to the consultation on Medical Device Regulations: Routes to market and in vitro diagnostic devices carried out last year....more
The Product Regulation and Metrology Act 2025 reforms the UK's post-Brexit product safety, metrology, and consumer protection frameworks....more
Pharma: Reform of the EU Pharmaceutical Legislation; German Medical Research Act enacted fostering R&D also including confidentiality of drug prices; France adopts standard CTA clauses; UK easing clinical trials; Devices:...more
As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more
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
The UK and India have announced one of the “biggest and most economically significant” bilateral trade agreements the UK has signed since Brexit, following years of discussions. This marks a significant milestone for the UK...more
On March 17, 2025, the government published a policy paper with an Action Plan for regulation and regulators, outlining how it intends to reform the UK's regulatory system to support growth and innovation. The Action Plan...more
In the EU, the AI Act has been approved, carrying significant implications for medical device, technology, and pharmaceutical firms. In the US, there is no comprehensive federal AI legislation, but at least 45 states have...more
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
On 11 December 2024, the MHRA published a revised roadmap for the long-awaited reforms to the UK Medical Device Regulations 2002 (MDR Roadmap). The updated MDR Roadmap provides additional clarity for industry on the intended...more
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced the five technologies selected to participate in the ‘AI Airlock Pilot’ for AI-powered medical devices. The pilot is a regulatory “sandbox” for...more
On 12 December 2024 the statutory instrument to amend the Medicines for Human Use (Clinical Trials) Regulations 2004 (UK CTR) was laid before Parliament. The Medicines and Healthcare products Regulatory Agency (MHRA),...more
Access to first-in-class medicinal products that can save and transform lives is crucial for patients in the UK – and the earlier the access, the more significant the impact. Equally vital, however, is that such products are...more
The MHRA has opened a consultation on proposed future pre-market requirements for medical devices and in vitro diagnostic devices (IVDs) in Great Britain. The consultation expands on proposals considered in the MHRA’s 2021...more
A draft Statutory Instrument was laid before UK Parliament on 22 October 2024 which, once passed, will introduce new post-market surveillance (PMS) requirements for medical devices and in vitro medical devices (IVDs) in the...more
The MHRA recently published an update on its plans for MedTech regulatory change. The update confirmed that the new framework will be introduced through four statutory instruments to update and replace the UK Medical Devices...more
Device manufacturers may soon have access to a new framework for marketing and selling medical devices in the United Kingdom. On May 21, 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published...more
The UK Medicines and Healthcare products Regulatory Agency (MHRA's) has published a Statement of policy intent: international recognition of medical devices outlining its proposal for the International Recognition Procedure...more
On 30 April 2024, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) published its strategic approach to AI and the steps it is taking to implement the UK Government's AI White Paper, published in August 2023....more
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
In Short - The Situation: The EU Product Liability Directive 85/374/EEC ("PLD") was adopted nearly 40 years ago and has remained almost unchanged since its inception....more
The UK Government has recently made available a draft of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2023 (2023 Regs). Although these are far from being in force yet,...more
The Medicines and Healthcare products Regulatory Agency recently published a Corporate Plan outlining their strategic priorities for the next three years. A key area of focus is international recognition, which follows their...more