Item 8.01 Other Events.
On October 27, 2022, NovoCure Limited (the "Company") reported in its Quarterly
Report on Form 10-Q for the period ending September 30, 2022 that as a result of
the implementation of the Medical Device Regulation, the Company's notified body
(as well as many other notified bodies throughout the European Economic Area
("EEA")) had suffered a significant backlog in issuing CE Certificate renewals
that that may have affected the Company's ability to obtain a renewal of a CE
Certificate for Optune before the current CE Certificate expired in October
2022. In the event of a gap between expiration of the current CE Certificate and
issuance of the renewal, the Company was permitted to continue to sell and
market CE marked Optune from current inventories in the EEA and Switzerland
under the expired CE Certificate. On November 4, 2022, the CE Certificate was
renewed and no disruption of sales of Optune occurred.
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