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New MEDICAL DEVICE REGULATION-MDR

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New MEDICAL DEVICE REGULATION-MDR

  1. 1. NEW MEDICAL DEVICE REGULATIONS- MDR Published by European Parliament and Council of European Union Mary Roopsy www.i3cglobal.com mrj@i3cglobal.com
  2. 2. Two new regulations that replace the medical device directives are  Regulation EU 2017/745 which replaces 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 and 93/42/EEC Mary Roopsy mrj@i3cglobal.com
  3. 3.  Regulation 2017/746 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU Mary Roopsy mrj@i3cglobal.com
  4. 4. These new MDR are released on April 5, 2017 and a transition period of 3 years , i.e 2020 for the medical devices and 5 years, i.e 2022 for the in vitro diagnostic medical devices are allowed. Through these new regulations the EU commission aims at the better protection of public health and patient safety. Mary Roopsy mrj@i3cglobal.com

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