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

May 16, 2019

DUBLIN--(BUSINESS WIRE)--May 16, 2019--

The “6-Hour Virtual Seminar - The New EU Medical Device Regulation” webinar 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

Agenda

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

View source version on businesswire.com:https://www.businesswire.com/news/home/20190516005894/en/

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Related Topics:Medical Devices

KEYWORD: EUROPE

INDUSTRY KEYWORD: HEALTH MEDICAL DEVICES

SOURCE: Research and Markets

Copyright Business Wire 2019.

PUB: 05/16/2019 12:22 PM/DISC: 05/16/2019 12:22 PM

http://www.businesswire.com/news/home/20190516005894/en