Learning Outcomes

The Three European Directives on Medical Devices

The Important Regulatory Changes in the European Market

Terms and Definitions

Publication of EU MDR and Important Points

Lesson Summary

This module explains the existing relevant European directives for the medical devices' sector in Europe and how these will be replaced with the new EU regulations. The module further elaborates the important changes, improvements, and timelines of enforcement for the new regulations. The module also incorporates important terms from the EU MDR regarding industry.

Technical Documentation & Post-market Surveillance

Classification of Devices and Route to Market

Economic Operations & Clinical Evaluation

In this module you will learn the technical documentation required for different classes of the medical devices as per the new EU MDR, the change in archiving period, Post-market surveillance etc. The module then discusses the criteria for classification of medical devices on elements of risk for the device. The module lists the 22 rules which govern the devices classification, and also share some steps as route to the market along-with different Economic Operators' roles in the sector.

Unique Device Identifier (UDI)

European Database on Medical Devices (EUDAMED)

In this module, the reporting mechanism and identification of the medical devices as per the new EU MDR regulations are uncovered. The identification mechanism is based on Unique device identifier (UDI) and the important elements within that. Furthermore it also covers details about reporting requirements of EUDAMED.

European Medical Device Regulations - Course assessment

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

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

This free online course explains the essentials of European Medical Device Regulations (EU MDR) - 2017/745. The 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 etc. This course will be interest to all professionals working in the medical devices' industry.

Origin and Context of ISO 13485:2016

Key Terms and Concepts in ISO 13485:2016

Application of ISO 13485:2016 in Industry

Core Requirements of the QMS

Management Responsibility and Resource Management

Product Realisation – From Planning to Development

Product Realisation – Purchasing and Production

Monitoring and Measurement Activities

Control of Non-Conforming Product

Analysis and System Improvement

ISO 13485:2016 Medical Device Quality Management Systems - Assessment

Explore the principles and implementation of ISO 13485:2016 medical device quality systems with this free online course.

ISO 13485:2016 Medical Device Quality Management Systems

Medical devices play a vital role in delivering safe, effective, and high-quality healthcare, as do the standards that ensure their reliability and performance. This course explores ISO 13485:2016, covering its principles, implementation, and continuous improvement. This course was reviewed and approved by subject matter expert Dr. Anadu Austin, a Medical expert and Consultant. Enrol now to build expertise in medical device quality management.

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