In 2012, the EU Commission adopted a package of measures on innovation in health. This free webinar will look at what to expect when the new regulation is implemented.
About this webinar
In 2012, the EU commission adopted a package of measures on innovation in health. The package consists of a communication and two regulation proposals to revise existing legislation
on general medical devices and in vitro diagnostic medical devices. In particular, the directives on active implantable medical devices (90/385/EEC) and on medical devices (93/42/EEC)
are intended to be replaced by a regulation on medical devices, while the directive on in-vitro diagnostic medical devices (98/79/EC) is intended to be replaced by a regulation on the same subject.
The revisions therefore 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.
The updated regulation
Implementation dates and transition
Main changes and products affected
Effect on medical device manufacturers
The current directive will be significantly altered
The new regulation will be legally binding on all EU member states