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Medical Devices › International Harmonization

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

Ropes & Gray LLP

Clinical Trial Protocol Deviations: A New FDA Draft Guidance to Ring in the New Year

Ropes & Gray LLP on

As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting protocol deviations in...more

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

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

Holland & Knight LLP

USTR Extends Section 301 Exclusions for COVID-19 Related Medical-Care Products

Holland & Knight LLP on

The Office of the U.S. Trade Representative (USTR) published a Notice in the Federal Register on Nov. 16, 2021, extending product exclusions for COVID-19-related products covered by USTR's Section 301 investigation into...more

Hogan Lovells

FDA delays draft rule for QSR/ISO 13485 harmonization

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) indicated that the long-anticipated proposed rule modernizing the Quality System Regulation (QSR) is now targeted for release in April 2020. This is the second delay in the agency's...more

Latham & Watkins LLP

Time to Prepare for New EU Medical Device Regime

Latham & Watkins LLP on

Companies should act now to prepare for the full implementation of the MDR and IVDR. On 26 May 2020, Regulation (EU) 2017/745 on medical devices (MDR) will become fully active, reflecting an overhaul of the current...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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