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Healthcare 2021 - 6-Hour Virtual Seminar on The New EU Medical Device Regulation

Date2021-05-28

Deadline2021-05-26

VenueOnline, USA - United States USA - United States

KeywordsHealthcare; HR Webinar; Medical online training

Websitehttps://www.gcplearning.com/virtual-semi...-11722LIVE

Topics/Call fo Papers

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 Seminar will look at what to expect when the new regulation is implemented. Including: the transition period, Effect on Notified Bodies, Impact of the MDR on Quality Management Systems (QMS), technical documentation, clinical trial requirements, UDI and combination products.

Last modified: 2021-05-03 17:57:17