Leica Biosystems Richmond, Inc

• Ensuring the technical documentation and the EU Declaration of Conformity are drawn up and kept up-to-date; • Investigational devices contain a signed statement required of Annex XIV Section 4.1 that the device conforms to the general safety and performance requirements apart from the aspects covered by the performance study.

• 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; • Ensure the post-market surveillance obligations in Articles 10(9) and 78 are complied with; • All vigilance reporting obligations referenced in Articles 82 to 86 are fulfilled.