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The Role Of The Contract Manufacturer Under The EU MDR & IVDR By Mark Durivage, Quality Systems Compliance LLC Regulation (EU) 2017/745 Medical Device (EU MDR) of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002, and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC Active Implantable Medical Devices Directive (EU AIMDD) and 93/42/EEC Medical Device Directive (EU MDD) was set for enforcement in May 2020. However, due to the global COVID-19 pandemic, the European Commission extended the date of application for EU MDR by 12 months, meaning medical device companies now have until May 26, 2021 to comply with MDR requirements.

Mark durivageCommission decisionEuropean parliamentEuropean commissionQuality systems complianceCouncil directivesImplantable medical devices directiveDevice directiveProcedure packsVitro diagnostic medical devicesVitro diagnostic medical devices directiveதரகு முடிவுஐரோப்பிய பாராளுமன்றம்ஐரோப்பிய தரகுதரம் அமைப்புகள் இணக்கம்சபை வழிமுறைகள்