IVDR 2017 746 regulatory affairs: Learn EU compliance
Understand regulations for Invitro diagnostic medical devices in simple terms to gain EU market approval
4.51 (227 reviews)
904
students
6.5 hours
content
Dec 2024
last update
$64.99
regular price
What you will learn
Understand European Union regulatory affairs for marketing an in vitro diagnostic medical device in the EU.
Why was there a change from the directive to the IVDR 2017 746?
The timelines for the transition of the IVDR 2017 746.
Economic Operators and their obligations. European Authorised Representative, Distributor, Importer and Manufacturer.
What is the obligation of a person responsible for regulatory compliance (PRRC)
Understand what EUDAMED is. What the requirements are and transitional timelines. The actors registration.
Unique Device Identification and registration. How a UDI carrier is created. Authorised UDI providers and the timelines to package device with the UDI carrier.
The student will learn how to classify an in vitro diagnostic medical device with examples, quizzes and guidance documents.
The student will learn how to choose a conformity assessment route for each particular classification of an in vitro diagnostic medical device.
Learn what is sufficient clinical data and how to collect it. What is meant by intended purpose and General Safety and performance requirements. (GSPR)
Learn the requirements of post market surveillance. What a periodic safety update report (PSUR) is. The student will learn the requirements of vigilance.
The student will learn the role of the medical device coordination group. MDCG
Learn what common specification and technical documentation means.
Understand the implications of Brexit on the IVDR 2017/746.
Understand how Switzerland, Turkey and the EFTA are affected by the IVDR 2017/746.
Understand what the EU commission rolling plan is.
Understand how the European Union Reference laboratories will support the implementation of the IVDR 2017 746
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3817966
udemy ID
01/02/2021
course created date
15/11/2021
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