IVDR CE is a mandatory certification for medical devices in theEuropean Union (EU), and is required by the Medical DeviceRegulation (MDR). CE certification ensures that medical devicesmeet the safety, performance and quality standards required by theEU.
The IVDR CE certification process involves several steps. Firstly,the manufacturer needs to determine the classification of theirproduct according to the MDR rules, as different classes mayrequire different levels of testing and documentation. Secondly,the manufacturer needs to prepare the technical documentationrequired for the CE certification, which includes a riskassessment, clinical evaluation, and user manual. Thirdly, themanufacturer needs to have their product tested by a Notified Body,a third-party organization accredited by the EU to perform CEtesting. Finally, the manufacturer needs to apply to their nationalauthority for authorization to market their product in the EU.
To apply for IVDR CE certification, manufacturers can eitherself-certify their product or use a Notified Body to perform thetesting and certification. Self-certification is only allowed forlow-risk medical devices in Class I, while all other classesrequire a Notified Body.
In addition to IVDR CE certification, manufacturers may also needto register their products with the European Database on MedicalDevices (EUDAMED). This involves submitting information such as theproduct's name, manufacturer, classification and intended use, aswell as updates on any changes to the product or manufacturer.
In summary, the IVDR CE certification and EU registration processcan be complex and involve several steps. However, by following theappropriate guidelines and working with a Notified Body ifnecessary, manufacturers can ensure that their medical devices meetthe safety and performance standards required for sale in theEU.
IVDR CE认证和欧代注册办理流程有哪些
更新:2024-09-15 08:15 发布者IP:113.116.241.6 浏览:0次- 发布企业
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产品详细介绍
成立日期 | 2017年12月17日 | ||
法定代表人 | 陈影君 | ||
注册资本 | 500 | ||
主营产品 | 临床试验、CE-MDR&IVDR、NMPA、FDA 510K、MDL等。 | ||
经营范围 | 产品认证,防疫物资检测,产品检测,质量检测报告,检测报告办理,CE认证办理,国内外检测认证办理。各国授权代表服务(殴代,美代,澳代)。医疗器械MDR IVDR 认证申请,美国FDA,澳洲TGA认证。 | ||
公司简介 | 广东省国瑞中安科技集团有限公司(简称“国瑞中安集团”)是一家专注于为医疗器械及体外诊断产品企业提供临床试验、全球法规注册和检验检测等综合技术服务的CRO。通过多年的发展和积累,我们已经在全球多个重要市场建立了完善的服务网络及专业的本地化团队。作为一家专业的综合性CRO,我们的主要服务项目包括:国内外临床试验、法规注册咨询(中国NMPA、俄罗斯RZN、欧盟CEMDR&IVDR、美国FDA&a ... |
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