1. MDR NEW DEFINITIONS AND TYPES OF TRIALS

Clinical Trials for Medical Devices in Europe - The New MDR
Duration:  Unlimited
Cost:  179  USD
PayPal
Learn the new definitions and types of trials contained in the MDR, understand when investigations are not required and much more.
Length: 00:20

2. MDR THE ACTORS: SPONSOR, INVESTIGATOR & SUBJECT

Clinical Trials for Medical Devices in Europe - The New MDR
Duration:  Unlimited
Cost:  179  USD
PayPal

This course presents an overview of the "actors" within the scope of the new MDR, namely the sponsors, investigators, and subjects. Learn all you need to know about how these "actors" play a significant role within the new MDR.

After the course, you can take a brief test to receive your certification. Enjoy!

Length: 00:15

3. MDR CONDITIONS, ETHICAL PRINCIPLES, METHODS, INFORMED CONSENT

Clinical Trials for Medical Devices in Europe - The New MDR
Duration:  Unlimited
Cost:  179  USD
PayPal
This lecture investigates the new Medical Device Regulation (MDR) with regard to conditions, ethical principles, methods and informed consent process. The intent of this tutorial is to describe the conditions for carrying out clinical investigations and to outline the rules laid down by MDR for particular clinical investigation types.
Length: 00:20

4. MDR STUDY APPLICATION AND APPROVAL - NEW COORDINATED ASSESSMENT

Clinical Trials for Medical Devices in Europe - The New MDR
Duration:  Unlimited
Cost:  179  USD
PayPal
Learn the new MDR rules for study application and approval process. The coordinated assessment procedure will streamline clinical investigations conducted in more than one EU Members State.
Length: 00:20

5. MDR SUBSTANTIAL STUDY CHANGES, TEMPORARY HALT AND TERMINATION

Clinical Trials for Medical Devices in Europe - The New MDR
Duration:  Unlimited
Cost:  179  USD
PayPal
This tutorial aims to provide an overview of the MDR provisions related to the end of the clinical investigation, along with an outline of the MDR rules concerning the extraordinary events which could happen during the clinical investigation (substantial modifications, corrective measures, temporary halt, early termination).
Length: 00:15

6. MDR ADVERSE EVENT REPORTING IN CLINICAL INVESTIGATIONS

Clinical Trials for Medical Devices in Europe - The New MDR
Duration:  Unlimited
Cost:  179  USD
PayPal
The purpose of this tutorial is to analyze the MDR provisions for adverse events recording and reporting to Competent Authorities. The topics addressed are: MDR references, Relevant definitions, Sponsor obligations in case of adverse events occurring during the clinical investigation and Regulatory comparison: MDD vs MDR.
Length: 00:15