The U.K.’s Life Sciences Council just updated its joint statement on a “golden opportunity” for medical devices regulatory reform, with ten “aligned proposals” to guide reform efforts. Proposals focus on encouraging innovation and the possibility of expanded recognition of other regulators’ device approvals.
Background on U.K. medical device regulation
After Brexit, the U.K. continued to follow the E.U. device and IVD directives in place since the mid-1990s. These directives covered the regulation of medical devices (“MDD”), active implantable medical devices (“AIMDD”), and in vitro diagnostic medical devices (“IVDD”).
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