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

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Description

MDR

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in its transition phase, at the end of which the current legislation of the Medical Devices Directive 93/42/EEC will be repealed and no longer apply in the EU.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.


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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.

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2 Days

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