DQS India is organizing 16 hours online Training Program on EU MDR

The new Regulation (EU) 2017/745 was published on May 5, 2017 and came into force on May 25, 2021. For manufacturers of already approved medical devices, there is a transition period until May 26, 2024, during which time devices formerly certified under the previous Medical Device Directive MDD 93/42/EEC may continue to be placed on the market, but are also subject to additional requirements under Regulation (EU) 2017/745.

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  • Introduction to EU Medical Device Regulation
  • Changes against past regulatory requirements
  • Contents of EU MDR 2017/745
  • Transition timelines
  • Scope of regulation
  • Common specifications
  • Classification of devices
  • Conformity assessment(s)
  • Clinical evaluation consultation procedure (scrutiny)
  • Obligations of economic operators

Auditors

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Girish Silswal
Moderator
Director & Head-Management System Assurance Business at DQS India

Training Program on EU MDR

Language : English
Location Price
Online
Online Book