definiens: means any governmental approvals, licenses, registrations, clearances or authorizations necessary for the marketing, sale, or use of an in vitrodiagnostic device ; provided that, ( a ) in the United States, as of the Effective Date RegulatoryApproval is only that sought from the Federal Food and Drug Administration, ( b ) in the EuropeanUnion, as of the Effective Date Regulatory Approval is only that sought through compliance withthe In Vitro Diagnostic Medical Devices Directive ( which on the Effective Date is Directive98/79 / EC ) and ( c ) in jurisdictions not requiring any governmental approvals, licenses, registrations, clearances or authorizations for the marketing, sale, or use of an in vitro diagnosticdevice, Regulatory Approval shall be deemed to have been provided for a particular in vitrodiagnostic device upon the first commercial sale or marketing of that in vitro diagnostic device ifthat in vitro diagnostic device would require Regulatory Approval in the United States if marketedin the United States