Draft Decision CEN/TC 206 003/2023 Medical devices utilizing human tissues and their derivatives — Application of risk management

Comment period start date: 04/08/2023 Comment period end date: 11/09/2023 Scope This document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of human origin. The materials are non-viable or have been rendered non-viable. The document specifies, in junction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices,…