Manufacturers, International Harmonization

European Commission publishes harmonised standards in support of the MDR and IVDR

Hogan Lovells on 1/13/2022

The European Commission adopted Implementing Decisions (EU) 2022/6 of 4 January 2022 and 2022/15 of 6 January 2022 regarding harmonised standards in support of Regulation (EU) 2017/745 (the "Medical Devices Regulation" -...more

Strategic Modern Slavery and Human Rights Risk Management: The UK Modern Slavery Act Four Years on

BCLP on 7/24/2019

When the Modern Slavery Act (“Act”) came into force in October 2015, it was the first legislation of its kind, aiming to tackle and eventually eliminate human trafficking and the various forms of modern slavery. It also...more

Overlapping Labels Can Lead to Liability

Williams Mullen on 8/12/2016

Multiple regulatory agencies worldwide exercise jurisdiction over how hazards associated with chemicals in the workplace are communicated to employees and others. This creates a complex web of requirements and...more

FDA Issues Final Rule on Use of Symbols in Labeling

Knobbe Martens on 7/7/2016

The Food and Drug Administration published a Final Rule in the Federal Register revising labeling regulations for medical devices and certain biological products to allow for the use of symbols without adjacent explanatory...more

FDA Issues Final Ruling Allowing Medical Device Manufacturers to Use Stand-Alone Symbols on Labels

Cozen O'Connor on 6/20/2016

This week, on June 14, 2016, the FDA issued a final ruling revising its medical device and certain biological product labeling regulations to allow, for the first time, manufacturers to use graphical representations of...more

Manufacturers › International Harmonization

European Commission publishes harmonised standards in support of the MDR and IVDR

Strategic Modern Slavery and Human Rights Risk Management: The UK Modern Slavery Act Four Years on

Overlapping Labels Can Lead to Liability

FDA Issues Final Rule on Use of Symbols in Labeling

FDA Issues Final Ruling Allowing Medical Device Manufacturers to Use Stand-Alone Symbols on Labels

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