Regulatory Oversight, Medical Devices, New Regulations

Staying Prepared Amid FDA Changes

Gardner Law on 5/30/2025

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

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

Hogan Lovells on 5/12/2025

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

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

A&O Shearman on 4/1/2025

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

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

Latham & Watkins LLP on 11/24/2021

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

New medical device regulation in Spain opened for public consultation

Hogan Lovells on 3/3/2020

Spain’s Ministry of Health initiated proceedings for approval of the new regulation on medical devices with a call for a prior public consultation to receive contributions from interested parties....more

Digital Health in the United Kingdom: The New Regulatory Environment Under the Medical Device Regulation

McDermott Will & Schulte on 7/3/2019

The MDR and other recent developments in the health care regulatory landscape pose new opportunities and challenges for medical software companies and investors in digital health in the United Kingdom. Although the regulatory...more

Paradigm Shift: Regulating Software as a Medical Device in the U.S.

Mintz - Health Care Viewpoints on 12/21/2018

The U.S. Food and Drug Administration (FDA) is exploring the development of a new regulatory approach for software as a medical device (SaMD) that the agency believes will promote innovation while still assuring device safety...more

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