体外诊断试剂IVD欧盟EN13612性能评估部分中英文.docVIP

3 General requirements for the performance evaluation 3.1 Responsibilities and resources The manufacturer takes the responsibility for the initiation and/or the conduct of a performance evaluation study. He shall define the responsibility and the interrelation of all personnel who manage and conduct the performance evaluation of IVD MDs, particularly for personnel who need the organisational freedom and authority to a) assess the validity of test results and data already available; b) specify performance claims which shall be further examined or confirmed; c) specify and document the evaluatio