6-Hour Virtual Seminar: The New EU Medical Device Regulation (29 May, 2019 – 11:00 EDT) – ResearchAndMarkets.com


Virtual Seminar – The New EU Medical Device Regulation”
has been added to ResearchAndMarkets.com’s offering.

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.

Who Should Attend?

  • Clinical Trial Managers
  • Regulatory Affairs
  • Medical Officers


1. The Updated Regulation

2. Implementation Dates & Transition

3. Main Changes & Products Affected

4. Effect on Medical Device Manufacturers

For more information about this webinar visit https://www.researchandmarkets.com/r/6cne5c


Laura Wood, Senior Press Manager
E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call
For GMT Office Hours Call +353-1-416-8900
Topics: Medical


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