May 17, 2018 | 9:00 AM | Thursday

Event Location

Hilton Zurich Airport

Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50, Zurich, Sw 8152

Neighborhood: Clinton

Call
Directions
Website

Description

The package consisted of a Communication and two regulation proposals to revise existing legislation on general medical devices and in vitro diagnostic medical devices.


Thu May 17, 9:00 AM - Fri May 18, 6:00 PM

Event Details

Overview:
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 will benefit:
• Clinical Trial Managers
• Regulatory Affairs
• Medical Officers
Agenda:
Day 1 Schedule
Lecture 1 (90 Mins):
The new MDR main changes
• Main updates
• Transition periods
• Effect on medical device manufacturers
• Regulatory landscape
Lecture 2 (90 Mins):
Notified Bodies under the New MDR
• Effect on NBs
• When will NBs begin conformity assessment against the new Regulation?
• Main effect on medical device manufacturers
Lecture 3 (90 Mins):
Impact of the MDR on Quality Management Systems (QMS)
• When do I need to update my QMS?
• What main points need to be considered?
• Effect on medical device manufacturers
Lecture 4 (90 Mins):
Technical Documentation
• Class I and I

New EU Medical Device Regulation | Updated Regulation 2018

People Attending

Event Feed

Also See other Events Listed in New York City

Find Events in New York City

Leave empty Dates for all upcoming Events

Upcoming Events at Clinton

Champion Safe Co. Oct 20 | 2:00 AM | Saturday
at Champion Safe Co.
Red Cliffs Family Dentist ST George UT - Dr. Kelly J. Olsen, DDS Oct 21 | 12:00 AM | Sunday
at Red Cliffs Family Dentist ST George UT - Dr. Kelly J. Olsen, DDS

Desktop Notification

212area.com would like to send you latest updates