Shikha Malik

Shikha Malik is Senior Regulatory Affairs Specialist, Medtronic, USA.

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    Transitioning from paper to electronic IFU for EU MDR 2017/745


    The European Union Medical Device Regulation (EU MDR) Regulation (EU) 2017/745[1] amends current the EU Medical Device Directive (MDD) ‘93/42/EEC’ and the EU Active Implantable Medical Device (AIMD) ‘90/385/EEC’ directives. The regulation governs the manufacturing and supply of medical devices in the European Region and its territories.