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Medical Devices › International Harmonization › Manufacturers

Hogan Lovells

Key takeaways – UK MHRA’s response to consultation on ‘Medical Devices Regulations: Routes to market and in vitro diagnostic...

Hogan Lovells on

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

Hogan Lovells

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

Hogan Lovells on

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

Knobbe Martens

FDA Issues Final Rule on Use of Symbols in Labeling

Knobbe Martens on

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

Cozen O'Connor

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

Cozen O'Connor on

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

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