Upcoming Events at WILL BE ANNOUNCED SOON
Wed Jun 27, 9:00 AM - Thu Jun 28, 6:00 PM
WILL BE ANNOUNCED SOON
WILL BE ANNOUNCED SOON, Chicago, il 60007
Community: Upper West Side
Description
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.
Event Details
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.
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 manufacture
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 manufacture
