The U.K.’s pending secession from the European Union prompted UL International to start closing up shop as a notified body for medical device approvals.
British voters in June 2016 approved withdrawing from the E.U. on a 51.9% to 48.1% vote. An initial Brexit deadline of March 29 was broken after Parliament voted three times to reject deals brokered with the E.U., raising the specter of a unilateral “no-deal” Brexit before the newest deadline of Oct. 31.
One consequence of a no-deal Brexit would be the loss by U.K. notified bodies of their accreditation with the EU, UL said, prompting it to set its own deadline of Sept. 1 for its withdrawal as a notified body.
UL said it transferred 80% of its CE Mark customers to Polish N.B. Polskie Centrum Badan I Certyfikacji and the remainder to another certified N.B.
“This will ensure that UL’s notified body customers will have continuous certification to enable them to continue to place products on the market and allow continued patient access to these devices,” the company said.
UL also said that it will restrict its in vitro diagnostic medical device designation, limiting its scope to a single test for trisomy 21.