Medical Device Regulation 2017/745 EU regulatory affairs.
Coupon Verified on October 28th, 2025
Course Name : Medical Device Regulation 2017/745 EU regulatory affairs.
Students : 5,530
Duration : 4 hours
Avg Rating : 4.4 (1,810 ratings)
Original Price : $119.99
Discount Price : $12
Instructor / Provider : Udemy
Course Type : Self Paced Online Course. Lifetime Access
Coupon : Click on ENROLL NOW to apply discount code
What you’ll learn
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Understand European Union regulatory affairs for marketing a medical device in the EU.
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Why was there a change from the directive to the MDR 2017 745?
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The timelines for the transition of the MDR 2017 745.
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Economic Operators and their obligations. European Authorised Representative, Distributor, Importer, Manufacturer and procedure pack & systems providers.
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What is the obligation of a person responsible for regulatory compliance (PRRC)
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Understand what EUDAMED is. What the requirements are and transitional timelines. The actors registration.
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Unique Device Identification and registration. How a UDI carrier is created. Authorised UDI providers and the timelines to package device with the UDI carrier.
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The student will learn how to classify a medical device with examples, quizzes and guidance documents.
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The student will learn how to choose a conformity assessment route for each particular classification of a medical device.
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Learn what is sufficient clinical data and how to collect it. What is meant by intended purpose and General Safety and performance requirements. (GSPR)
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Learn the requirements of post market surveillance. What a periodic safety update report (PSUR) is. The student will learn the requirements of vigilance.
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The student will learn the role of the medical device coordination group. MDCG
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Learn what common specification and technical documentation means.
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Understand the implications of Brexit on the MDR 2017/745.
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Understand how Switzerland, Turkey and the EFTA are affected by the MDR 2017/745.
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Understand what the EU commission rolling plan is.
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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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Yes, Medical Device Regulation 2017/745 EU regulatory affairs. coupon code is valid for the first 1,000 enrollments or for 30 days, whichever comes first. After that, the coupon will expire.
Is Medical Device Regulation 2017/745 EU regulatory affairs. free download available?
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Can I get a refund for the Medical Device Regulation 2017/745 EU regulatory affairs. course, If I purchased with a coupon?
Yes, Udemy offers a 30-day money-back guarantee for all courses purchased on the website, even if you used a coupon to purchase the course.
