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Regulation (EC) No 765/2008 of the European Parliament and of... 3. 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Q5m+Y"Jd-,*8,>[(`OE?XlZ^>K0>LadfW#+E8:$4Ri.IiJO;S^D2)hT&? >> >> 44 0 obj stream >> /Length 1849 !l]bT;UD#q(7Ch08N\1DLKhA[#rVFJ*BUm:PX0Uea>'I These annexes state - mostly in tabular form - whether the standard is suitable or which chapter or paragraph of the standard is suitable to cover the essential requirement(s) of the corresponding annexes of the Medical Devices Directive 93/42/EEC, the Active Implant Directive 90/385/EEC and the In-Vitro-Diagnostic Medical Devices Directive 98/79/EC. dP,i$(8m@@]4uK?Kl#NtZlHH=Dp-;Y)K]lkEc3@G>QA+:(doaqDI9V0)?a,PV0/m@ << 92 0 obj I*re]>0oc1g&]QS'>Pd;phMq:8EF%WP0-GB2I?>r&Z'p&>a,jr;K2J+?$3X.L5L!i ?uV(aRgNMlZH'J/6\!HkIP?9^7Wj(400&&f*k3:95&'+=C$%mFbstE9WQ'P5&1:O)@9O << On Friday 27 April 2012, the European Commission published updated lists of the European harmonized standards that pertain to the Medical Devices Directive (93/42/EC), In Vitro Diagnostics Directive (98/79/EC), and the Active Implantable Medical Devices Directive (90/385/EEC). 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