July 20, 2017

July 20, 2017

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July 19, 2017

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July 18, 2017

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European Union Addresses Use of Nanomaterials in Medical Devices

On April 5, 2017, the European Parliament (EP) approved a regulation on medical devices, as well as a regulation on in vitro diagnostic medical devices.  The EP’s April 5, 2017, press release states that the medical devices regulation is intended to ensure that medical devices are traceable and comply with European Union (EU) safety requirements.  The medical devices regulation addresses the use of nanomaterials in medical devices.  The European Commission’s April 5, 2017, fact sheet states that the critical factor in classifying devices incorporating or consisting of nanomaterials is the potential for nanomaterials to be in contact with membranes inside the body.  Those devices presenting a high or medium potential for such contact will be in the highest risk class and thus be subject to the most stringent conformity assessment procedures.  To allow manufacturers and authorities time to implement the regulations, the regulation on medical devices includes a three-year transition period, and the regulation on in vitro diagnostic medical devices includes a five-year transition period.

©2017 Bergeson & Campbell, P.C.

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About this Author

Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
Managing Partner

Owner of Bergeson & Campbell, P.C. (B&C®), Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy...

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Carla Hutton, Bergeson Campbell PC, global regulatory attorney, public health activists lawyer, metals industry legal counsel, Toxic Substances Control Act law
Regulatory Analyst

Since 1996, Carla Hutton has monitored, researched, and written about regulatory and legislative issues that may potentially affect Bergeson & Campbell, P.C. (B&C®) clients. She is responsible for creating a number of monthly and quarterly regulatory updates for B&C's clients, as well as other documents, such as chemical-specific global assessments of regulatory developments and trends. She authors memoranda for B&C clients on regulatory and legislative developments, providing information that is focused, timely and applicable to client initiatives. These tasks have proven invaluable to many clients, keeping them aware and abreast of developing issues so that they can respond in kind and prepare for the future of their business.

Ms. Hutton brings a wealth of experience and judgment to her work in federal, state, and international chemical regulatory and legislative issues, including green chemistry, nanotechnology, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Toxic Substances Control Act (TSCA), Proposition 65, and the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program.

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