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Understanding the European Medical Device Regulation Requirements (EU MDR)

Qualifying People - Developing Future

What is EU MDR?

Implementation of European Medical Device Regulations (EU MDR) is the primary requirement for compliance to the regulatory requirements in the European market for the Medical Device manufacturers and to place CE marking on the products. The European Council Directives 90/385/EEC and 93/42/EEC has been revised to Regulation (EU) 2017/745. European Medical Devices Regulation (MDR), was published in the official Journal of the European Union on May 5, 2017. The Regulation (EU) 2017/745, covers medical devices and active implantable medical devices. This regulatory frame work defines the expectations of European Commission, as well as medical device manufacturers, notified bodies and member state competent authorities.

course content / outline

Understanding the European Union Medical Device Regulation Requirements:

  • Introduction to EU Medical Device Regulation
  • Transition Timelines 
  • Key definations
  • Scope and applicability
  • Classification rules
  • Conformity assessment
  • Specific procedures – scrutiny
  • Economic operators and their obligations
  • Person responsible for regulatory compliance
  • Documentation requirements
  • Post market surveillance system
  • EUDAMED database and Unique Device Identifier (UDI)
  • Question and Answer Session
  • Test

Who should attend?

Manufacturers of medical devices, especially: Regulatory Affairs, Design and Development, Clinical Affairs Specialists, Quality Management, and Quality Assurance personnel.

training duration

1 Day

Exam details

Participants will be assessed through a 50 marks written examination at the end of the course. Minimum passing criteria: 60%.

Certification

All Participants who have completed the training will be issued a TÜV SÜD South Asia’s certificate of attendance.

 

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