definiens: shall mean ( i ) all laws, statutes, constitutions, treaties, rules, regulations, ordinances, codes ofconduct, statutory guidance, codes and guidance having the force of law, directives and regulations ; and ( ii ) alljudicial, executive, legislative or administrative orders, directives, decrees, injunctions, judgments, permits, agreements, and other legal requirements both ( i ) and ( ii ) applicable to the manufacture, import, export and distributionof the Contract DBS Test Kits in the Territory, including the collection of the Patient ’s informed consent, andapplicable to the performance of Diagnostic Testing Services, including but not limited to Directive 98/79 / EC regardingin vitro diagnostic medical devices, applicable national laws on medical devices in the Territory : and ( iii ) all applicableguidance documents and guidelines on medical devices applicable in the Territory, including but not limited to theMEDDEV guidance documents in its current versions