Four-Year Transitional Period Expected for Certain Low-Risk Devices Including Software Under Changes to EU Medical Devices Regulation

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On November 25, 2019, a draft corrigendum to the Medical Devices Regulation (MDR) was published. The draft proposes a four-year transitional period for some low-risk medical devices including certain software currently classified as Class I under the current legislation, which will become a higher risk class under the MDR.

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