Medical Devices: EU Regulations

Medical device manufacturers face global economic challenges in an ever-changing regulatory environment. These changes come in the form of more stringent and complex regulations, a constantly evolving state-of-the-art, higher patient expectations and commercial pressures. As the regulatory profession continues to grow in importance and prominence, regulatory professionals have become key contributors to a company’s ability to devise successful but still regulatory-compliant business strategies and execute these strategies effectively. Therefore, they need to build robust regulatory expertise by continuously sharpening, maintaining and expanding their skills, knowledge and understanding of relevant and applicable regulations and emerging technologies.

This course provides a solid understanding of medical device regulation in the EU. It covers the history of medical device regulation in Europe and follows the regulatory requirements throughout the product lifecycle. You will gain a strong foundation of the key elements of the EU regulations governing medical devices. These include: Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 in their latest revision. This course examines the regulatory requirements that need to be met before and after placing a medical device on the market in the EU.

In this course, we will focus on the two new EU medical device regulations:

Regulation (EU) 2017/745 on medical devices (abbreviated as MDR)
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (abbreviated as IVDR)

At a Glance

Target Audience: This program is designed for new regulatory professionals and others in related departments interested in understanding the basics of EU regulation of medical devices.
Learning Level: Basic
Total Length of Course: 5 Hours
RAC Points: 5
Medical Device Certificate Elective
Enrollment Period: 12 months

Learning Objectives

Upon completion of this course, participants should be able to:

Explain the overall regulatory requirements for medical devices in the EU
Explain and differentiate between the scope of the two EU medical device regulations
Outline how medical devices are classified using the European regulatory framework
Identify the important contents of each EU regulation
Discuss the general requirements of preclinical and clinical testing in Europe
Describe the conformity assessment pathways for obtaining CE marking
Cite the key requirements for postmarketing surveillance

Lesson Titles

Lesson 1: Introduction to the Regulation of Medical Devices in the EU
Lesson 2: The Medical Devices Regulation (MDR) According to (EU) 2017/745
Lesson 3: The In-vitro Diagnostic Medical Device Regulation (IVDR) - (EU) 2017/746
Lesson 4: Standards, Common Specifications, Quality Assurance and Risk Management
Lesson 5: Postmarketing Requirements

This course is also included in:

Certificate in Medical Devices Regulations

Certificate in Medical Devices and Pharmaceuticals Regulation

RAC (Devices) Prep Bundle + Courses

RAC (Devices) Prep Bundle + Courses (Digital)

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