EU new Regulatory Framework - MDR and IVDR
This module looks back into the history of EU regulations for medical and in-vitro diagnostic devices, introduce the stakeholders and institutions within the new regulatory framework and set the transition timelines of moving from directive to regulation.
It will then focus on the key changes ushered in by the MDR and IVDR, outline the General Safety and Performance Requirements (GSPR) and map out the regulatory pathways by device risk class for medical and in-vitro diagnostic devices.
It will then focus on the key changes ushered in by the MDR and IVDR, outline the General Safety and Performance Requirements (GSPR) and map out the regulatory pathways by device risk class for medical and in-vitro diagnostic devices.
English
100% Online
150 minutes
APACMed Certificate
Assessments
Interactive
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This module has been co-developed by Philippe Auclair
This module has been co-developed by Dr. Adelheid Schneider
This module has been co-developed by Dr. Susanne Braun
About this Module
Why should I enrol in this Module?
This module looks back into the history of EU regulations for medical and in-vitro diagnostic devices, introduce the stakeholders and institutions within the new regulatory framework and set the transition timelines of moving from directive to regulation.
It will then focus on the key changes ushered in by the MDR and IVDR, outline the General Safety and Performance Requirements (GSPR) and map out the regulatory pathways by device risk class for medical and in-vitro diagnostic devices.
It will then focus on the key changes ushered in by the MDR and IVDR, outline the General Safety and Performance Requirements (GSPR) and map out the regulatory pathways by device risk class for medical and in-vitro diagnostic devices.
Who should enrol in this Module?
This Module is suitable for all Regulatory Affairs professionals or anyone with an interest in the regulation of medical devices.
How is this Module structured?
This is a self-paced, interactive Module. It is divided into a number of individual topics so you can easily track your progress and manage your time.
You must watch all of the videos and presentations before the section will be marked as complete.
You can view the structure and individual topics below.
You must watch all of the videos and presentations before the section will be marked as complete.
You can view the structure and individual topics below.
What kind of assessment do I need to do?
This Module contains a number of short knowledge checks and a final assessment.
You will have unlimited attempts to pass each knowledge check.
You will have unlimited attempts to pass each knowledge check.
What will I learn?
When will I get my certificate?
At the completion of the course you will immediately have access to the certificate from APACMed.