1. NEW MEDICAL DEVICE
REGULATIONS- MDR
Published by European Parliament and
Council of European Union
Mary Roopsy
www.i3cglobal.com
mrj@i3cglobal.com
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. 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. 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