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

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.

Sidley Austin LLP provides this information as a service to clients and other friends for educational purposes only. It should not be construed or relied on as legal advice or to create a lawyer-client relationship. Readers should not act upon this information without seeking advice from professional advisers. In addition, this information was not intended or written to be used, and cannot be used, by any person for the purpose of avoiding any U.S. federal, state or local tax penalties that may be imposed on such person.

Attorney Advertising—Sidley Austin LLP, One South Dearborn, Chicago, IL 60603. +1 312 853 7000. Sidley and Sidley Austin refer to Sidley Austin LLP and affiliated partnerships, as explained at

© Sidley Austin LLP