MDR中要求说明书应包含关于任何剩余风险和任何非预期副作用的信息,即没有与该器械相关的任何剩余风险或非预期副作用可以免于信息披露。SSCP应包含至少与说明书相同的剩余风险和非预期副作用的信息。 For the purpose of the SSCP, an undesirable effect can be understood as any undesirable side-effect related to...
The main purpose of this document is to provide guidance on the presentation, content and validation of the SSCP. The word “shall” is used when there is a corresponding “shall” in the MDR, otherwise “should” or “recommended” etc. is used indicating the interpretation of the MDR. 本...
Updates to the SSCP/SSP that require validating and are outside the scope of the PSUR evaluation will require additional technical documentation to be submitted to perform the validation (e.g., CER, PMCF/PMPF plans) and therefore will need to be performed as a separate technical documentation a...
In the third and final webinar of the series withRonald Boumans, senior consultant for regulatory affairs at Emergo by UL we learned on the importance of Summary of Safety and Clinical Performance (SSCP) guidelines. SSCP is a critical component of the European Medical Device Regulation (MDR). ...
All these documents are part of the technical documentation, within the framework of CE marking procedures for devices, regardless of the device class. DOWNLOAD THE GUIDE share linkedintwitterEmail Events Find an answer to the challenges you are facing in one of our upcoming event...
The MDCG is composed of representatives of all Member States and it is chaired by a representative of the 本文件已得到医疗设备协调小组(MDCG)的认可,该小组是根据《条例》(欧盟)2017/745条设立的。千年发展目 European Commission. 标协商小组由所有成员国的代表组成,并由欧洲委员会的一名代表担任主席。
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