definiens: means any governmental approvals, licenses, regis trations, clearances or authorizations necessary for the marketing, sale, or use of an in vitro diagnostic device ; provided that, ( a ) in the United States, as of the Effective Date Regulat ory Approval is only that sought from the Federal F ood and Drug Administration, ( b ) in the European Union, as of the Effective Date Regulatory Approval is only t hat sought through compliance with the In Vitro Diagnos tic Medical Devices Directive ( which on the Effecti ve Date is Directive 98/79 / EC ) and ( c ) in jurisdictions not requiring any governmental approvals, licenses, re gistrations, clearances or authorizations for the marketing, sal e, or use of an in vitro diagnostic device, Regulat ory Approval shall be deemed to have been provided for a particu lar in vitro diagnostic device upon the first comme rcial sale or marketing of that in vitro diagnostic device if that in vitro diagnostic device would require Regul atory Approval in the United States if marketed in the Un ited States