临床评价相关要求
新法规提出:
1.要求根据Article61和附录XIV partA执行、评估、报告和更新临床评价资料;
2.提出对特定III类和IIb类器械,CER中要考虑咨询专家小组的意见;
3.对植入和III类器械,提出考虑临床研究;
4.要求CER按照PMCF取得数据进行更新;
5.针对III类和可植入器械,提出了CER更新的频率;
6.明确证明实质等同性需考虑的特点;
7.要求其与风险管理的相互作用
Relevant requirements for clinical evaluation
The new regulations propose:
1. It is required to implement, evaluate, report and updateclinical evaluation data according to Article 61 and Appendix XIVpartA;
2. Propose that the opinions of the consulting expert groupshould be considered in CER for specific Class III and IIbdevices;
3. For implants and Class III devices, clinical research shouldbe considered;
4. Require the CER to update the data obtained according toPMCF;
5. For Class III and implantable devices, the frequency of CERupdate is proposed;
6. Specify the characteristics to be considered for provingsubstantive equivalence;
7. Requirements for interaction with risk management