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Discover the comprehensive regulations of the European Union’s Medical Device Regulation (MDR) 2017/745 with our interactive course. We delve into the intricate laws governing medical device safety, efficacy, and quality – covering topics from market release requirements to identification and traceability methods.
The course also explores the role of notified bodies, conformity assessments, clinical evaluations, and more. Crucially, you’ll learn about post-market surveillance practices, vigilance, market surveillance, and the use of the European Database on Medical Devices (Eudamed).
In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.
Lesson 1: Lesson 1: Scope and Objectives of MDR 2017/745
Lesson 2: Regulation Outline – Chapters and Annexe
Lesson 3: Requirements for Market Release
Lesson 4: Identification and Traceability
Lesson 5: Notified Bodies
Lesson 6: Conformity Assessment
Lesson 7: Clinical Evaluation and Clinical Investigation
Lesson 8: Post-Market Surveillance, Vigilance and Market surveillance
Lesson 9: European Database on Medical Devices (Eudamed)