摘要
随着Ro HS指令修订,Ro HS 2.0被纳入为有源医疗器械产品CE认证必须符合的指令之一。2014年7月22日,MDD指令(93/42/EEC)中的有源医疗器械产品投放欧盟市场必须符合Ro HS 2.0要求。2016年7月22日,IVD指令(98/79/EC)的有源医疗器械产品投放欧盟市场必须符合Ro HS 2.0要求。一旦违规,企业将可能受到欧盟的处罚及造成重大损失,甚至禁止企业产品的出口,这在电子产品业界已早有先例。Ro HS 2.0指令要求医疗器械企业必须建立内部过程管理控制,供应链及物料符合性评价,产品符合性验证及制作技术文档等工作,来确保医疗器械产品持续符合Ro HS的要求。SGS凭借多年专业技术及服务经验,能为医疗器械企业满足Ro HS 2.0提供系统和有效措施以确保产品的合规性,帮助医疗器械企业更快进入目标市场创造更大的价值。
With the RollS directive recast, Rolls 2.0 become one of directives that active medical device should compliance with when apply for CE certification. Active medical device in the scope of Medical device directive （93/42/EEC） placing on the market must compliance with RoHS 2.0 directive requirement after July 22, 2014. And Active medical device in the scope of in vitro diagnostic medical devices （98/79/EC） placing on the market should meet the requirements of RollS 2.0 after July 22, 2016. Manufacturer will be disciplined by the European Union and caused significant losses if not conform to RollS, even more serious, products would prohibit of export. Event like that have been happen in electrical and electronic industry. Establish internal control process, assess compliance of materials in supplier chain, verify Rolls product conformity for RollS and prepare technical documentation are the base requirements of RoHS. Active medical device manufacturer should meet those requirements to assure their products continue compliance with RollS. With professional skill and many years of experience, SGS can provide systematic and effective measures to assure the conformity of RollS. In addition, we also can help medical device manufacture enter the target market, improve the efficiency of management, and create greater value.
出处
《中国医疗器械信息》
2014年第11期35-37,共3页
China Medical Device Information
