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News and Views March 2017

New Medical Device Regulation (MDR) in Europe
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8. Medical Device Networking Meeting
Hanover, April 27, 2017




Contact MDSS

MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

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

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New Vigilance Email Address


1. Special vigilance e-mail account for our clients:  vigilance@mdss.com

MDSS established a new e-mail account (vigilance@mdss.com) which is reserved for all vigilance matters like incident and Field Safety Corrective Action reports. This account is specifically monitored for all communication concerning vigilance events.

Some of you may have noticed that BfArM requested upon incident notification a non personalized e-mail within their responses.  We do not see this as a requirement but such an account does have its advantages.  Therefore the new account is intended to be used by our clients as well as with all communications with the authority.  Most certainly, someone will be behind this account but it will be a group of individuals such as Ulrike, Gesine and myself.  Should you wish to send a communication in regards to a vigilance event directly to someone, is also possible but in any case please copy vigilance@mdss.com. 

As always we monitor via all communication channels (phone fax e-mail etc.) any market surveillance information which will be provided by anyone concerning your products.

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