Medical Device Regulation Implementation Training Course (EU) 2017/745
The course covers the requirements of MDR EU/2017/745. Delegates will participate in class discussion and exercises, as well as lecture, to facilitate understanding of the application of risk management to medical devices
The MDR was published in the EU official Journal on the 5th May 2017, formally coming into force on the 25th May 2017. The MDR becomes fully applicable after a 3-year transition period on 26th May 2020.
The MDR is now in its transition phase, at the end of which the current legislation of the Medical Devices Directive 93/42/EEC will be repealed and no longer apply in the EU. In the transition period, a device could be CE Marked under either the current Directive or the new Regulation, dependant on the designation of Notified Bodies to the new Regulation and expiry date of certificates under the Directive.
Please see the
Objectives
IMPLEMENTATION COURSE CONTENT:
Introduction & Background
Scope & Definitions
Conformity assessment procedures
Quality management system requirements
General safety and performance requirements
Technical file requirements
Clinical evidence requirements
Alignment with MEDDEV 2.7.1 rev 4
Post-market surveillance & vigilance
Risk management requirements
Identification & traceability
Supply chain requirements
Notified Bodies
Transition and Next Steps
Business Impact, Timeline and Portfolio Planning
Audience
This course is aimed at organisations undergoing the transition from the Medical Devices Directive 93/42/EEC to the Medical Devices Regulation which becomes fully applicable on 26th May 2020 after a 3-year transition period.
View Details
{2BC4CCAB-D0D5-461E-BD54-AD3E1D369CE1}
2 Days
+ VAT
System is currently experiencing issues and we are working on a solution. If you encounter an error, please come back shortly and try again.