體外診斷試劑歐盟CE認(rèn)證詳解-IVDD 98/79/EC要求
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體外診斷試劑出口歐盟需按照體外診斷器械指令I(lǐng)VDD 98/79/EC要求進(jìn)行認(rèn)證
98/79/EC Scope法規(guī)范圍：
This Directive shall apply to in vitro diagnostic medicaldevices and their accessories. For the purposes of this Directive,accessories shall be treated as in vitro diagnostic medical devicesin their own right. Both in vitro diagnostic medical devices andaccessories shall hereinafter be termed devices.
體外診斷試劑CE認(rèn)證要求
1 工廠要滿足ISO 13485醫(yī)療體系的要求
2 準(zhǔn)備CE技術(shù)文件：產(chǎn)品介紹，使用說明書、風(fēng)險(xiǎn)分析報(bào)告、包裝標(biāo)簽樣本等
3 按照IVDD 98/79/EC 附錄III的要求簽發(fā)EC合格聲明
EC DECLARATION OF CONFORMITY下載
4 制造商需去成員國(guó)的主管當(dāng)局competent authorities注冊(cè)，若制造商非歐盟公司，需委托歐盟代表幫助制造商完成注冊(cè)
98/79/EC Article 10 Registration of manufacturers anddevices
1. Any manufacturer who places devices on the market under hisown name shall notify the competent authorities of the Member Statein which he has his registered place of business:
— of the address of the registered place of business,
— of information relating to the reagents, reagent products andcalibration and control materials in terms of common technologicalcharacteristics and/or analytes and of any significant changethereto including discontinuation of placing on the market; forother devices, the appropriate indications,
— in the case of devices covered by Annex II and of devices forself-testing, of all data allowing for identification of suchdevices, the analytical and, where appropriate, diagnosticparameters as referred to in Annex I, part A, section 3, theoutcome of performance evaluation pursuant to Annex VIII,certificates and any significant change thereto, includingdiscontinuation of placing on the market.
關(guān)于‘’歐代‘’請(qǐng)見：醫(yī)療器械、醫(yī)療體外診斷試劑等歐盟代表ECRepresentative如何申請(qǐng)？
5 按照98/79/EC Article 16要求加貼CE標(biāo)識(shí)
98/79/EC Article 16 CE marking
Devices, other than devices for performance evaluation,considered to meet the essential re referred to inArticle 3 must bear the CE marking of conformity when they areplaced on the market.
擁有英國(guó)BSI、德國(guó)TUV、土耳其UDEM等**公告機(jī)構(gòu)授權(quán)，可提供專業(yè)高效的醫(yī)療器械和醫(yī)療器械體外診斷試劑的CE認(rèn)證服務(wù)。
第三方檢測(cè)認(rèn)證服務(wù)，電子電器安規(guī)EMC檢測(cè)，材料有害物質(zhì)RoHS檢測(cè)，產(chǎn)品包裝運(yùn)輸可靠性測(cè)試
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