Introduction to MDR

A three-day course covering the EU Medical Device Regulation (2017/745) which has replaced the earlier Medical Devices Directive (93/42/EEC).

The European Unions revised Medical Device Regulation (2017/745) entered into force in 2017 and became fully effective on May 26, 2021. This course provides knowledge of the requirements of the regulations, including the requirements for technical documentation and quality system requirements.

Objective

Upon successful completion of the course, attendees will be able to:

  • Analyze the differences between the regulations of MDD (Medical Devices Directory) and MDR (Medical Devices Regulation);
  • Understand the structure of the MDR;
  • Understand essential requirements of the MDR;
  • Understand certification processes at a Notified Body.

Audience

This course is suitable for:

  • Managers and personnel responsible for the CE certification of medical devices;
  • Regulatory affairs officers responsible for certification for medical devices;
  • Quality assurance personnel responsible for device and system compliance;
  • CE certification consultant of medical devices.


All our public courses can also be delivered in-house at your premises either as standard or tailored depending on the needs and requirements of your business.

To find out which training courses we offer in your country, click on "Find a local course", select your country and navigate to Medical devices; or Contact us if you are interested or want to know more on in-house courses.

The European Unions revised Medical Device Regulation (2017/745) entered into force in 2017 and became fully effective on May 26, 2021. This course provides knowledge of the requirements of the regulations, including the requirements for technical documentation and quality system requirements.

Objective

Upon successful completion of the course, attendees will be able to:

  • Analyze the differences between the regulations of MDD (Medical Devices Directory) and MDR (Medical Devices Regulation);
  • Understand the structure of the MDR;
  • Understand essential requirements of the MDR;
  • Understand certification processes at a Notified Body.

Audience

This course is suitable for:

  • Managers and personnel responsible for the CE certification of medical devices;
  • Regulatory affairs officers responsible for certification for medical devices;
  • Quality assurance personnel responsible for device and system compliance;
  • CE certification consultant of medical devices.


All our public courses can also be delivered in-house at your premises either as standard or tailored depending on the needs and requirements of your business.

To find out which training courses we offer in your country, click on "Find a local course", select your country and navigate to Medical devices; or Contact us if you are interested or want to know more on in-house courses.