Essentials of European Medical Device Regulations (EU MDR) - 2017/745

Q: What is meant by the EU 2017 745 MDR regulation?

The EU 2017/745 MDR (Medical Device Regulation) is a regulatory framework that governs the marketing and use of medical devices in the European Union, focusing on their safety, performance, and quality. It replaces the previous Medical Device Directive (MDD) and aims to enhance patient safety and device traceability. Update your training with the free course Essentials of European Medical Device Regulations .

Q: What are the common EU MDR specifications?

The common EU MDR specifications are the standardised requirements that provide detailed guidance on specific aspects of medical device regulations, ensuring consistent application and evaluation across the European Union.

Q: What is the goal of the MDR regulation?

The purpose of the Medical Device Regulation (MDR) is to ensure the safety, effectiveness, and quality of medical devices within the European Union while improving transparency and traceability throughout the supply chain.

Q: What’s the best course in the latest European Medical Device Regulations?

Alison’s Essentials of European Medical Device Regulations course provides a way for learners to study the complex and detailed regulations, including the improvements in the EU MDR, the technical files elements, post-market responsibilities, increased requirements related to market actors, and more.

In this free online course learn about the key aspects of the European Medical Device Regulations (EU MDR) - 2017/745.

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Avg. Duration1.5-3 Hours
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Learning Outcomes

After completing this course you will be able to:

Explain the three directives on medical devices: IVDD, MDD & AIMDD
Discuss the transformation of old EU directives into new regulations, and their relationships
Summarize the important improvements with the new EU MDR
Differentiate the different classes of medical devices and the criteria for classification
List the 22 rules of product classification for a medical device
Interpret the route to market for medical devices in Europe
Evaluate the roles of different economic operators in EU
Describe the applications and requirements of EU-UDI
Specify the requirements on EUDAMED in EU MDR

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