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娆х洘濮斿憳浼氬彂甯冭缁哢DI鎸囧崡

瀹為獙瀹よ祫璁綉鏃堕棿:2019-05-16 鐐瑰嚮: 娆?/span> 鐧惧害鎼滅储

銆愬璇汇€?/strong>娆х洘濮斿憳浼氬懆浜斿彂甯冧簡涓変唤鏂囦欢锛屽叾涓寘鎷細鍏充簬鍖荤枟鍣ㄦ娉曡锛圡DR锛夊拰锛圛VDR锛夌殑鏂囦欢锛岃缁嗚鏄庡皢鏉ュ摢浜涘叧浜庡敮涓€璁惧鏍囪瘑绗︼紙UDI锛夌殑鏁版嵁闇€瑕佹彁渚涚粰鍖绘鍜孖VD鐨凟udamed鏁版嵁搴撲腑锛屼互鍙婁竴浠藉叧浜嶦udamed鍖绘鏁版嵁妫€绱㈢殑鏂囦欢銆?闄ゅ埗閫犲晢鍚嶇О鍜屽熀鏈琔DI-DI鍊煎锛孧DR鏂囦欢杩樿杩颁簡鍙﹀涓€浜涜姹傦紝鍖呮嫭闃愭槑璇ュ櫒姊版槸......
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娆х洘濮斿憳浼氬彂甯冭缁哢DI鎸囧崡

娆х洘濮斿憳浼氬懆浜斿彂甯冧簡涓変唤鏂囦欢锛屽叾涓寘鎷細鍏充簬鍖荤枟鍣ㄦ娉曡锛圡DR锛夊拰锛圛VDR锛夌殑鏂囦欢锛岃缁嗚鏄庡皢鏉ュ摢浜涘叧浜庡敮涓€璁惧鏍囪瘑绗︼紙UDI锛夌殑鏁版嵁闇€瑕佹彁渚涚粰鍖绘鍜孖VD鐨凟udamed鏁版嵁搴撲腑锛屼互鍙婁竴浠藉叧浜嶦udamed鍖绘鏁版嵁妫€绱㈢殑鏂囦欢銆?/p>

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涓婁釜鏈堬紝娆х洘鍖荤枟鍣ㄦ鍗忚皟灏忕粍锛圡DCG锛夊彂甯冧簡涓や唤鏂囦欢锛岃В閲婁簡鍦ㄦ病鏈塙DI鐨勬儏鍐典笅锛岃€佹棫鍣ㄦ濡備綍鍙互鍦‥udamed娉ㄥ唽锛屼互鍙婂尰姊板巶瀹跺彲浠ュ湪2021骞?1鏈堜箣鍓嶅湪Eudamed娉ㄥ唽璁惧淇℃伅銆?/p>

鐩稿叧閾炬帴锛?/p>

鍖荤枟鍣ㄦ锛圡DR锛夐渶瑕佹彁渚涚粰Eudamed鐨刄DI鍜屾暟鎹俊鎭?br> https://ec.europa.eu/docsroom/documents/35241?locale=en
浣撳璇婃柇璁惧锛圛VDR锛夐渶瑕佹彁渚涚粰Eudamed鐨刄DI鍜屾暟鎹俊鎭?br> https://ec.europa.eu/docsroom/documents/35242?locale=en
Eudamed鍖绘UDI鏁版嵁妫€绱㈡枃浠?br> https://ec.europa.eu/docsroom/documents/35243?locale=en
锛堟湰鏂囨潵婧愶細鍖荤枟鍣ㄦ鍒涙柊缃戠炕璇?锛?

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