Medical Device Regulation – MDR 2017/745

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.

Curriculum:

Introduction

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)

Glossary

Evaluation