Introducing Medical Device Regulation (8 hrs)

Course Code: ISO13485-IMDR-04

The European Union’s Medical Devices Regulation (MDR 2017/745/EU) was officially published on 5 May 2017 and came into force on 25 May 2017. It will eventually replace the Medical Device Directive (MDD 93/42/EEC) and Active Implantable Medical Device Directive (AIMD 90/385/EEC). Manufacturers of currently approved medical devices under MDD and AIMD will have a transition time of three years until 26 May 2020 to meet the requirements of the MDR. For certain devices, this transition can be extended until 26 May 2024.

The MDR introduces numerous changes, including shift from pre-approval stage to life-cycle approach. It also incorporates European guidance documents (MEDDEVs) into the regulation and emphasizes the importance of Post-Market Surveillance (PMS), clinical data, clinical evaluation and Post-Market Clinical Follow-up (PMCF). MDR compliance presents many new challenges to medical device manufacturers.

  • Know the fundamentals of MDR
  • Learn MDR requirements
  • Introduction to MDR
  • Classification of medical devices
  • Conformity assessment procedure
  • Technical documentation requirement
  • General safety and performance requirements
  • Clinical data and clinical evaluation requirements
  • Post-market surveillance, vigilance and market surveillance requirements

Participants will learn through lectures, case studies, group exercises and discussions.

This course is suitable for:

  • Medical device professionals in quality and risk management, research and development, manufacturing, etc.
  • Anyone who is working in the medical device sector that market products to the EU

Duration : 1 day (8 hrs)
Time : 9:00am – 6:00pm

Course Fee : $450.00
Nett Fee Incl. 7% GST : $481.50

(A course in partnership with TÜV SÜD)

Key Benefits
  • Know the fundamentals of MDR
  • Learn MDR requirements
Course Contents
  • Introduction to MDR
  • Classification of medical devices
  • Conformity assessment procedure
  • Technical documentation requirement
  • General safety and performance requirements
  • Clinical data and clinical evaluation requirements
  • Post-market surveillance, vigilance and market surveillance requirements
Learning Methodology

Participants will learn through lectures, case studies, group exercises and discussions.

Who Should Attend

This course is suitable for:

  • Medical device professionals in quality and risk management, research and development, manufacturing, etc.
  • Anyone who is working in the medical device sector that market products to the EU
Course Details

Duration : 1 day (8 hrs)
Time : 9:00am – 6:00pm

Course Fee : $450.00
Nett Fee Incl. 7% GST : $481.50

(A course in partnership with TÜV SÜD)

Course Application

Details Registration
February 11, 2020 - February 11, 2020 (9:00 am - 6:00 pm) Closed