CEFLA s.c.

• Ensure that the reporting obligations of art. 87 to 91 are met by monitoring the QMS • Ensure that PMS obligations of art. 10, par. 10 are met by collecting data on the quality, performance and safety of devices; ensuring implementation and monitoring any necessary actions; • Ensure that the reporting obligations of art. 87 to 91 are met with regard to: Collection and analysis of reports of serious accidents (art. 87); Collection and analysis of data to generate trend reports (art. 88)

• Ensure drafting of technical documentation and EU declaration of conformity • Ensure that obligations arising from PMS of art. 10 par. 10 are met with regard to technical documentation • Perform the registration of Cefla in Eudamed (art. 31 point 5). • Ensure timely updates on EUDAMED related to: all serious accident reports (art. 87); trend reports (art. 88); device registration (art. 29 point 4); PSURs; Safety Warnings (art. 89) • Ensure the compliance of devices before release

• Ensure that the reporting obligations of art. 87 to 91 are met by monitoring the QMS • Ensure that PMS obligations of art. 10, par. 10 are met by collecting data on the quality, performance and safety of devices; ensuring implementation and monitoring any necessary actions; • Ensure that the reporting obligations of art. 87 to 91 are met with regard to: Collection and analysis of reports of serious accidents (art. 87); Collection and analysis of data to generate trend reports (art. 88)