Medical Device Regulation 2017/745 EU regulatory affairs.

Understand regulations for medical devices in simple terms to gain market approval of a medical device in the EU.

4.52 (1587 reviews)

Udemy

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English

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What you will learn

Understand European Union regulatory affairs for marketing a medical device in the EU.

Why was there a change from the directive to the MDR 2017 745?

The timelines for the transition of the MDR 2017 745.

Economic Operators and their obligations. European Authorised Representative, Distributor, Importer, Manufacturer and procedure pack & systems providers.

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 a medical device with examples, quizzes and guidance documents.

The student will learn how to choose a conformity assessment route for each particular classification of a 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 MDR 2017/745.

Understand how Switzerland, Turkey and the EFTA are affected by the MDR 2017/745.

Understand what the EU commission rolling plan is.

The MDR 2017/745 will help the student how to be compliant to ISO 13485 and a Quality Management System for a medical device manufacturer.

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Our Verdict

This course offers a solid foundation in understanding EU MDR and its requirements, with an easy-to-understand approach to complex regulatory materials. However, there is room for improvement in terms of engagement and up-to-date information. While mostly suitable for beginners, incorporating more real-life examples, varied question formats in quizzes, and current amendments would benefit learners at all levels.

What We Liked

Comprehensive coverage of the 2017/745 EU regulatory affairs for marketing a medical device in the EU
Easy-to-understand explanations and accessible approach to complex MDR material
Actionable resources, diagrams, and additional reading materials provided
Instructor's active engagement with student questions in the Q&A section

Potential Drawbacks

Quizzes could be more engaging with varied question formats
Minor inconsistencies in terminology, such as referring to 'PRRC' as 'Regularity' or 'Regulation'
Lack of current amendments regarding extensions of timelines for devices (published in 2023)
Dry presentation style focusing solely on explaining the regulation without many case studies