The New EU Medical Device Regulation - Webinar

  • ID: 4534986
  • Webinar
  • 60 Minutes
  • NetZealous LLC
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Overview:
Regulation proposals of the European Commission

Background

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. 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.

This webinar will look at what to expect when the new regulation is implemented.

Why should you Attend: Because the current Directive will be significantly altered and replaced by a Regulation which is legally binding on all Member States.

Areas Covered in the Session:

The Updated Regulation
Implementation Dates and Transition
Main Changes and Products Affected
Effect on Medical Device Manufacturers
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  • Salma Michor Salma Michor,


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  • Clinical Trial Managers
  • Regulatory Affairs
  • Medical Officers
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