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News and Views March 2017

New Medical Device Regulation (MDR) in Europe
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The "NEW CE" mark
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8. Medical Device Networking Meeting
Hanover, April 27, 2017



CONTACT

MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

Phone
(+49)-511-6262 8630
FAX
(+49) -511-6262 8633

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European CE IVD & Medical Device Regulations


Dear valued customer,

MDSS would like to inform you that the European Commission has submitted the proposals for the new CE IVD Device & Medical Device Regulations to the European Parliament and Council.


The Regulations becomes a binding Union law after the Parliament and Council adopt the texts, (a regulation does not have to be first transposed into Member State legislation before becoming effective). There is a legislative procedure which the proposal must go through. The target adoption is 2014 and the new rules may gradually come into effect from 2015 to 2019.


As soon as MDSS becomes aware of the official adoption we will of course inform our clients.   However, we wanted to inform you of the proposals at this time as there will be quite an impact if adopted in full.


In our opinion some manufacturers may get "caught out in the rain" if not addressing the aspects early on. For this reason MDSS is recommending to review the proposals early on to determine the possible impact on company procedures and device compliance. The following is the link to European Commission website where the proposals are published Please click here


If you have further questions please do not hesitate to contact us via
info@mdss.com or call +49 511 6262 8630.

Your MDSS Team