Training Program on EU MDR

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.

• 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