MD Directive to MD Regulation Transition - International Training

Niveau Spécialiste Durée 1 journée de formation

Disponible pour réserver: Salle de classe virtuelle 1190€ + TVA View dates and book your 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

Manufacturers of medical devices, especially: Regulatory Affairs, Design and Development, Clinical Affairs Specialists, Quality Management, and Quality Assurance personnel.
By the end of the course delegates will be able to:
- Explain the changes in the structure and administration of the regulation
- Recognize new economic operators affected by the regulation
- Identify key changes to the requirements concerning the following steps for conformity assessment:
- Check device is within the scope of the MDR
- Determine risk class of device
- Select conformity assessment procedure
- Identify applicable safety and performance requirements
- Assemble technical documentation
- Apply conformity assessment procedure
- Assign unique device identification (UDI)
- Complete Declaration of Conformity (DoC)
- Affix CE mark
- Post-Market Surveillance and Updates
- Explain the main impacts on the QMS relating to the above steps, including:
- Frequency, extent and conduct of audits
- Electronic data management and public access to data
- Clinical investigations, clinical evaluation and post-market surveillance
- Roles of commercial partners
- Communicate the transition arrangements as stipulated within the regulation
- Course materials, provided electronically
- Letter of attestation
- Official certificate
Assessment specifics
- Questionnaire to assess the knowledge at the end of the training
- Customer survey
Course materials including :
- Introduction to the training, detailed programme and security assignments
- Course presentation, theory and activities/ role plays
- Answers to the activities
- Videos
- Additional documents, distributed during the sessions, to use for the activities
- Attendance sheet to be signed
This guide will give you all the necessary information.
Download our training guide: MD Directive to MD Regulation Transition
* These training modules are eligible to the subsidizing by the public institutions in France (OPCO).

**Each delegate receives a training convention after enrollment.

***Please note that for the public sessions, you have until 48h before the start of the course to confirm your enrollment. 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.

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