Join us at this years Regulatory Affairs Summit in Prague, 24-26 October, 2017October 06, 2017
New EU regulation on Medical devices, coming into force starting from 2017
"Ongoing revision: Regulation proposals of the European Commission In 2012, the Commission adopted a package of measures on innovation in health.
The package consisted of a Communication and two regulation proposals to revise existing legislation on general medical devices and in vitro diagnostic medical devices. The revisions affected all kinds of medical devices including in vitro diagnostic medical devices, from home-use items like sticking plasters, pregnancy tests and contact lenses, to X-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests."
Read European Commission's full article HERE.
This means changes in classification for Medical devices, requirements for registration and distribution. We would kindly invite you to register for our open class on 9- 10 November 2017, where all those topics are going to be looked through and discussed.
Thanks to all who participated in ERA 2017 event in MallorcaJuly 27, 2017
Thanks to all who participated in Pharmacovigilance Strategy CourseMay 11, 2017
eCTD format only! From January 1, 2020May 02, 2017
eSubmissions Course, 6 - 7 April 2017, Riga, LatviaApril 10, 2017
Good Manufacturing Practice Course 2017 in Riga, LatviaMarch 21, 2017
European and US regulators agree on mutual recognition of inspections of medicines manufacturersMarch 06, 2017
EXTEDO Announces New Regional Partnership with Rephine Balticum for the Baltic and CIS regionFebruary 09, 2017
Ukrainian government simplifies registration of medicines from the U.S., EU and certain other developed countriesJanuary 16, 2017
New EU regulation on Medical devices, coming into force starting from 2017January 16, 2017