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New Draft from EU on MDR

New Draft from EU on MDR

by Jack Slovick | Oct 8, 2015 | EU

The EU Council has released a draft of their position on the proposed MDR and IVDR. On 5 October 2015, the Ministers of the EU countries agreed on the General Approach of the position. The Council, Parliament, and Commission will negotiate the various proposals into...

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510k AIMDD CDRH Draft EAR EN EU Europa European Norm FDA FDIS Food and Drug Administration GUDID ISO ISO/FDIS 9001 IVDD IVDR MDD MDR Medical Device Directive OJEU Quality Management Refuse to Accept RTA UDI

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