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[CE/MDR, IVDR] Guideline on UDI system
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2018-11-05 19:45:00
http://en.icmcert.com/bbs/board7_4/268724 URL COPY

http://icmcert.com/bbs/link.php?bo_table=sub04_06&wr_id=575&no=1&page=10

2018 년 10 월, 유럽 위원회 (European Comission) 에서는 UDI system 에 대한 5가지 가이드라인을 발표했습니다. 자세한 사항은 아래 내용을 확인해주시기 바랍니다.


1. MDCG 2018-3: Guidance on UDI for systems and procedure pack

2. MDCG 2018-4: Definitions/Descript-xions and formats of the UDI core elements for systems or procedure packs

3. MDCG 2018-5: UDI Assignment to Medical Device Software

4. MDCG 2018-6 Clarifications of UDI related responsibilities in relation to Article 16

5. MDCG 2018-7 Provisional considerations regarding language issues associated with the UDI database

자세한 내용은 첨부 링크를 참조해주시기 바랍니다.

감사합니다.
 

 

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