EU MDR

EU Medical Device Regulation (EU MDR) – Chapter 2: Making Available on the Market

Welcome to EU MDR 2017/745 – Module 2 – Chapter II – Making Available on the Market and Putting into Service of Devices, Obligations of Economic Operators, Reprocessing, CE Marking, Free Movement.

This Chapter expands on some of the definitions given in Chapter I and introduces activities to be undertaken by Economic Operators before a product is placed on the market, when it is placed on the market and after it is placed on the market in the European Union.

CEU Credits: 0.1

Course Code: ELM-318

Duration: 60 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.0

Curriculum for this course

Introduction

Overview

Previous Module

Module Introduction

Learning Objectives for this Module

Articles 5 to 9

Article 5 - Placing on the Market and Putting into Service

Article 6 - Distance Sales

Article 7 - Claims

Article 8 - Use of Harmonized Standards

Article 9 - Common Specifications

Articles 10 to 16

Article 10 - General Obligations of Manufacturers – Part 1

Article 10 - General Obligations of Manufacturers – Part 2

Article 11 - Authorized Representative – Part 1

Article 11 - Authorized Representative – Part 2

Article 12 - Change of Authorized Representative

Article 13 - General obligations of Importers – Part 1

Article 13 - General obligations of Importers – Part 2

Article 14 - General obligations of Distributors

Article 15 - Person Responsible for Regulatory Compliance – Part 1

Article 15 - Person Responsible for Regulatory Compliance – Part 2

Article 16 - Cases in which Obligations of Manufacturers Apply to Importers, Distributors or Other Persons

Articles 18 to 20

Article 18 - Implant Card and Information to be Supplied to the Patient with an Implanted Device

Article 19 - EU Declaration of Conformity

Article 20 - CE Marking of Conformity

Articles 17 to 23

Article 17 - Single-Use Devices and their Reprocessing

Article 21 - Devices for Special Purposes

Article 22 - Systems and Procedure Packs – Part 1

Article 22 - Systems and Procedure Packs – Part 2

Sterilization of Systems and Procedure Packs

Article 23 - Parts and Components

Article 24 - Free Movement

Article 24 - Free Movement

Conclusion

Final Assessment

Certification

Author

Ian Nicholls

Director at Explic8

Courses

Browse our extensive catalog of GxP, Corporate Compliance and EH&S training.

Learning Strategy

Boost your organization’s training with LearnGxP’s Learning Strategy Consultants (LSC). They customize learning paths to match your needs, offering ongoing support for lasting success.

Customer Stories

Discover how LearnGxP addresses real challenges, provides effective solutions, and positively impacts our customers’ organizations.