F1ANNEXES

F1ANNEX IXCONFORMITY ASSESSMENT BASED ON A QUALITY MANAGEMENT SYSTEM AND ON ASSESSMENT OF TECHNICAL DOCUMENTATION

F1CHAPTER IIASSESSMENT OF THE TECHNICAL DOCUMENTATION

F15.Specific additional procedures

F15.3.Procedure in the case of devices manufactured utilising, or incorporating, tissues or cells of human or animal origin, or their derivatives, that are non-viable or rendered non-viable

F15.3.1.Tissues or cells of human origin or their derivatives

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F15.3.2.Tissues or cells of animal origin or their derivatives

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .