Module 3 - Strategic case studies in practice

II.

LIST OF ABBREVIATIONS

769 770 771 772 774 775 776 777 778 779 780 781 782 783 784 785 786 787 788 789 790 791 792 793 794 795 796 797 798 799 800 801 802 803 804 805 806 807

III. ASSESSMENT OF THE GENERAL SAFETY AND PERFORMANCE REQUIREMENTS 773 (GSPR)

a. Basis of assessment, Article 117 of Regulation EU 2017/745.

In consideration of the following text from Article 117 of the Medical Device Regulation (EU 2017/745), [sic]… “Where, if the dossier does not include the results of the conformity assessment referred to in the first subparagraph and where for the conformity assessment of the device, if used separately, the involvement of a notified body is required in accordance with Regulation (EU) 2017/745, the authority shall require the applicant to provide an opinion on the conformity of the device part with the relevant general safety and performance requirements (GSPR) set out in Annex I to that Regulation issued by a notified body designated in

accordance with that Regulation for the type of device in question.”

b. General Drug-Device Combination product information.