New EU regulation on Medical devices, coming into force starting from 2017 January 16, 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.