体外诊断试剂IVD欧盟EN13612性能评估部分中英文.doc

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 evaluation plan and the test procedures; d) prepare the evaluation report. The manufacturer shall appoint a co-ordinator with overall responsibility of the performance evaluation study. The co-ordinator shall himself assure that adequate resources are available. The investigator shall ensure that the evaluation plan is followed at his location and that the study is appropriately reviewed from an ethical point of view. 3.2 Documentation The documentation of the performance evaluation study shall contain the files relating to clauses 3 to 7 of this standard and shall be part of the technical documentation of the IVD MD. 3.3 Final assessment and review The co-ordinator shall assess and document which performance claims are met, state whether claims are not met and give recommendations for corrective actions, where necessary. The responsible management of the manufacturer shall make sure that the results of the performance evaluation study and the recommendations for corrective actions are carefully considered and properly documented before issuing a declaration of conformity. 4 Organisation of a performance evaluation study 4.1 Preconditions Before starting a performance evaluation study it shall be ensured by the co-ordinator that a) the performance claims of the IVD MD which are the subject of the study are specified; b) the IVD MD has been manufactured under controlled production proces