Medical Device Regulation - Implementing The Changes Training Bundle

OBJECTIVES

This course will provide participants with an overview of the critical changes in relation to EU Medical Device Regulation, along with the implementation timescales.

AUDIENCE

This course is intended for, but not limited to, regulatory personnel, managers, CEO, CFO, or any medical device or IVD field personnel who want to learn about the new regulations

DESCRIPTION

MDR

The MDR was published in the EU official Journal on the 5^th May 2017, formally coming into force on the 25^th May 2017. The MDR becomes fully applicable after a 3-year transition period on 26^th 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in its transition phase, at the end of which the current legislation of the Medical Devices Directive 93/42/EEC will be repealed and no longer apply in the EU.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 Medical Device Regulation Implementation Training Course (EU) 2017/745 Synopsis for a more comprehensive overview of this course and to review any pre-course requirements that may apply.

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.