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Two Day Course: New EU Medical Device Regulation (Chicago, IL, United States - June 27-28, 2018) - ResearchAndMarkets.com

May 16, 2018

DUBLIN--(BUSINESS WIRE)--May 16, 2018--The “The New EU Medical Device regulation” conference has been added to ResearchAndMarkets.com’s offering.

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.

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.

Why you should 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

Who Should Attend:

Clinical Trial Managers Regulatory Affairs Medical Officers

For more information about this conference visit https://www.researchandmarkets.com/research/k685f4/two_day_course?w=4

View source version on businesswire.com:https://www.businesswire.com/news/home/20180516006342/en/

CONTACT: ResearchAndMarkets.com

Laura Wood, Senior Manager

press@researchandmarkets.com

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Related Topics:Medical Devices

KEYWORD: EUROPE

INDUSTRY KEYWORD: HEALTH MEDICAL DEVICES

SOURCE: Research and Markets

Copyright Business Wire 2018.

PUB: 05/16/2018 03:06 PM/DISC: 05/16/2018 03:06 PM

http://www.businesswire.com/news/home/20180516006342/en

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