New EU Medical Device Regulation Course (Opfikon, Switzerland - May 17-18, 2018) - ResearchAndMarkets.com
DUBLIN--(BUSINESS WIRE)--May 14, 2018--The “The New EU Medical Device Regulation” conference has been added to ResearchAndMarkets.com’s offering.
Course “The New EU Medical Device regulation” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
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 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.
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/wmhkzr/new_eu_medical?w=4
View source version on businesswire.com:https://www.businesswire.com/news/home/20180514006328/en/
Laura Wood, Senior Manager
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Related Topics:Medical Devices
KEYWORD: EUROPE SWITZERLAND
INDUSTRY KEYWORD: EDUCATION HEALTH MEDICAL DEVICES TRAINING
SOURCE: Research and Markets
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PUB: 05/14/2018 04:07 PM/DISC: 05/14/2018 04:07 PM