Winter Springs, Fla.-based Iradimed said the Jan. 17 expiration came after its notified body, UL International, reviewed its technical file and found that it ran afoul of new EU clinical evaluation rules.
UL International granted a temporary, six-month EC certificate for products other than the 3880 monitor, “during which time we expect to cure the non-conformity and be permitted to again use the CE Mark on our 3880 patient vital signs monitoring system,” Iradimed said.
“This action is not the result of safety, effectiveness or performance issues,” the company said. “This action does not impact sales of our 3880 patient vital signs monitoring system in the U.S. or in other markets that do not require a CE Mark for importation purposes.”
“Despite the retrospective application of new guidance to our previously cleared 3380 MRI-compatible patient vital signs monitoring system, we are fully cooperating and in direct discussions with UL to agree upon the necessary and proper application of the new guidance. We believe that data collection, documentation and UL’s review of the required information will take between three to four months, after which time we believe UL will renew the EC Certificate, once again permitting use of the CE Mark on our MRI compatible patient vital signs monitoring system. We expect to fully resolve this matter prior to the end of our second quarter,” president & CEO Roger Susi said in prepared remarks. “We expect this action may reduce full-year 2019 revenue by approximately 2%. After considering this impact, we still expect mid-20% revenue growth in 2019. We will provide our full-year 2019 revenue, GAAP and non-GAAP earnings guidance in our fourth quarter earnings release.”