Leica Biosystems Melbourne Pty Ltd

• Ensuring the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; • Informing the notified body which approved the quality management system of any plan for substantial changes to the quality management system, or the device-range covered; • Shall grant the notified body access to the technical documentation.

• Ensuring the conformity of the devices is appropriately checked, in accordance with the quality management system • Informing the notified body for substantial changes to the quality management system, or the device-range covered; PMS obligations in Articles 10(9)&78 are complied with; vigilance reporting obligations in Articles 82 to 86 are fulfilled; investigational devices meet Annex XIV 4.1 & conform to the GSPR apart from aspects covered by the performance study;

Ensure device conformity is checked in accordance with the QMS before a device is released; maintain technical documentation (TD) and EU DoC; PMS obligations in Articles 10(9)&78 are complied with; vigilance reporting obligations in Articles 82 to 86 are fulfilled; investigational devices meet Annex XIV 4.1 & conform to the GSPR apart from aspects covered by the performance study; inform the notified body (NB) of any plan for substantial changes to the QMS or devices; grant NB access to TD.