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Life Sciences Unique Device Identifiers

McGuireWoods LLP

Medical Device Legal News with Sam Bernstein: Episode 18

McGuireWoods LLP on

This episode, Sam is joined by Sophie Mouros to discuss: a clinical trial fraud case involving allegedly fabricated data, the FDA’s withdrawal from the medical device Global Harmonization Working Party, the FDA’s recent...more

Morgan Lewis

FDA Extends UDI and Direct Marking Enforcement Discretion for Class I and Unclassified Devices to 2022

Morgan Lewis on

The US Food and Drug Administration’s recent policy, issued in part due to the coronavirus (COVID-19) pandemic, also suspends enforcement of Direct Marking requirements for certain Class I, Class II, Class III, and...more

Sheppard Mullin Richter & Hampton LLP

New EU Rules for Medical Devices

After four years of negotiations, European lawmakers agreed on June 15 on a new EU Medical Devices Regulation (MDR). The MDR is the equivalent to the FDA’s CDRH regulations in the United States and essentially specifies...more

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