MD Directive to MD Regulation Transition - International Training

This course introduces you to the key changes from the European Medical Device Directive (MDD) to the new European Medical Device Regulation (MDR). All medical devices and identified devices without a medical purpose will need to undergo a conformity assessment procedure based on the new MDR requirements, in order to place devices on the European Union market.

The course will give a general guideline of how to approach application of the new MDR, and will highlight the differences to the MDD that will affect all manufacturers.

Prerequisites

You should have a good understanding of the existing Medical Devices Directive (93/42/EEC).

Pedagogical objectives

  • Understand the key changes in the transition from the Medical Devices Directive to the new Medical Devices Regulation
  • Communicate the impact to your organization of the key changes introduced by the MDR, and the transition arrangements defined within the MDR
  • Identify the next steps for your organization to meet the MDR requirement

These training modules are eligible to the subsidizing by the public institutions in France (OPCO);

*Each delegate receives a training convention after the enrolment.

**Please note that for the public sessions, you have until 48h before the start of the course to confirm your enrolment. For the in-house sessions, the deadline would be of two weeks prior to the start of the course.

***Should you be in a disabled situation, please contact us and indicate what details should be taken into account.

You can contact us on training.france@bsigroup.com or 01 89 79 00 40

international training

Do you need more information?

If you have any concerns, please do not hesitate to contact our service department on the following numbers:

Telephone: 01 89 79 00 40
Email: training.france@bsigroup.com Or via the webchat service on our website: bsigroup.com


You will be put in touch with our team if necessary.

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