Medical Device Regulation Implementation Training Course (EU) 2017/745

Description

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its transition phase, at the end of which the current legislation of the Medical Devices Directive 93/42/EEC will be repealed and no longer apply in the EU.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

Objectives

This course will help you to understand:

• The MDR’s additional requirements
• The current directives – MDD 93/42/EE and ISO 13485:2016
• Terminology and certification requirements

Audience

This training course is for:

• Regulatory personnel
• Managers
• CEOs
• CFOs
• IVD device industry employees
• IVD device users
• Anyone who wants to learn about the new regulation