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
should attend?
  • Regulatory affairs professionals
  • Medical officers
  • Clinical trial managers
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