Practical Regulatory Affairs: EU Medical Device Regulations

Describes the three existing medical device Directives: the MDD, IVDD and AIMDD, and their replacement by the EU MDR

Understand the key changes between the old Directives and the new Regulations

Learn which entities and organisations enforce medical device legislation in the EU.

Understand the overall regulatory pathway to be followed to gain CE marking under the MDR in the EU.

Understand the "risk classification" approach used in the EU to classify devices into one of four device classes

Practice applying the device classification Rules to six medical device examples.

This lecture provides a walk-through of the device classification exercise presented in Lecture 12. Students will be able to see in real-time how each device classification was obtained.

Learn what options are available for us to demonstrate conformity with the MDR, including when and how a Notified Body needs to be involved

Learn about what a QMS is and the role it plays in the Regulatory Submission requirements.

Understand the key elements that needed to be included in the Technical Documentation as per Annex II and III of the MDR.

Identify the key elements and information that should be included in the device description.

Learn about device labelling requirements and the implementation of UDI in Europe under the MDR.

Learn about the requirements for Device Design and Manufacturing section.

Learn what the GSPRs are and how we can demonstrate that they have been addressed in the Technical Documentation.

High-level overview of risk management activities

Outlines the information needed in the product verification and validation sections, including the Clinical Evaluation Report (CER)

Learn about the Technical Documentation required related to Post-Market Surveillance

Learn about Declaration of Conformity (DoC) Document

Learn about the CE marking process for the MDR and the role of the Notified Body