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 Regulatory Approval is o nly that sought from the Federal Food and Drug Administratio n, ( b ) in the European Union, as of the Effective Date Regulatory Approval is only that sou ght through compliance with the In Vitro Diagnostic Medical Devices Directive ( which on the Effective Dat e is Directive 98/79 / EC ) and ( c ) in jurisdictions not requiring any governmental app rovals, licenses, registrations, clearances or authorizations for the marketing, sale, or use o f an in vitro diagnostic device, Regulatory Approval shall be deemed to have been provided for a particular in vitro diagnostic device upon the first commercial sale or marketing of that in v itro diagnostic device if that in vitro diagnostic device would require Regulatory Approval in the Uni ted States if marketed in the United States