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Why must a non-EU manufacture of medical device appoint a European Authorized Representative?医疗器械欧盟代表  

2012-03-30 13:20:05|  分类: 默认分类 |  标签: |举报 |字号 订阅

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Why must a non-EU manufacture of medical device appoint a European Authorized Representative?

The European Union's 'New Approach Directives' are mandatory on all member countries to enact through national legislation. This legislation requires manufacturers to display Why must a non-EU manufacture of medical device appoint a European Authorized Representative?医疗器械欧盟代表 - 医疗企业咨询--焰阳 - 医疗健康世界 Marking on their products, packaging and accompanying literature. Where a new approach directive is in force, it is (with few exceptions) "an offense to place a product on the market without Why must a non-EU manufacture of medical device appoint a European Authorized Representative?医疗器械欧盟代表 - 医疗企业咨询--焰阳 - 医疗健康世界 Marking". The manufacturer is legally responsible for ensuring that the product confirms to the requirements of the directive and for applying Why must a non-EU manufacture of medical device appoint a European Authorized Representative?医疗器械欧盟代表 - 医疗企业咨询--焰阳 - 医疗健康世界 Marking.

For medical devices, it is compulsory, under the 3 Medical Devices Directives, that the non-EU manufacturer must appoint an Authorized Representative (authorised representative) which must be established (have a registered business) in the European Union member states to act on manufacturer's behalf in carrying out certain tasks including:
Dealing with the regulatory authority;
Keeping, for a period extending to at least five (5) years after manufacture of the product, the updated Technical Documentation (or Technical File) available, in a timely fashion when called upon, for review and inspection by EU Competent and/or Surveillance Authorities;
Register, Update, and/or Notify class I, and IVD, Medical Devices with the EEA Competent Authorities;
Assisting in Vigilance/Incident Reporting, Product Recalls and the issuing of Advisory Notices.

 

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