EU Medical Device Regulation (EU MDR) – Chapter 2: Making Available on the Market
Description:
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.
Curriculum for this course:
Introduction
| Overview | 1 min 01 secs |
| Previous Module | 58 secs |
| Module Introduction | 1 min 11 secs |
| Learning Objectives for this Module | 1 min 10 secs |
Articles 5 to 9
| Article 5 – Placing on the Market and Putting into Service | 1 min 15 secs |
| Article 6 – Distance Sales | 1 min 10 secs |
| Article 7 – Claims | 1 min 08 secs |
| Article 8 – Use of Harmonized Standards | 1 min 17 secs |
| Article 9 – Common Specifications | 1 min 23 secs |
Articles 10 to 16
| Article 10 – General Obligations of Manufacturers – Part 1 | 1 min 12 secs |
| Article 10 – General Obligations of Manufacturers – Part 2 | 1 mins 29 secs |
| Article 11 – Authorized Representative – Part 1 | 1 min 02 secs |
| Article 11 – Authorized Representative – Part 2 | 1 min 25 secs |
| Article 12 – Change of Authorized Representative | 1 mins 11 secs |
| Article 13 – General obligations of Importers – Part 1 | 1 min 38 secs |
| Article 13 – General obligations of Importers – Part 2 | 1 mins 23 secs |
| Article 14 – General obligations of Distributors | 1 min 11 secs |
| Article 15 – Person Responsible for Regulatory Compliance – Part 1 | 1 min 14 secs |
| Article 15 – Person Responsible for Regulatory Compliance – Part 2 | 1 min 01 secs |
| Article 16 – Cases in which Obligations of Manufacturers Apply to Importers, Distributors or Other Persons | 1 min 22 secs |
Articles 18 to 20
| Article 18 – Implant Card and Information to be Supplied to the Patient with an Implanted Device | 1 min 01 secs |
| Article 19 – EU Declaration of Conformity | 1 min 13 secs |
| Article 20 – CE Marking of Conformity | 1 min 33 secs |
Articles 17 to 23
| Article 17 – Single-Use Devices and their Reprocessing | 1 min 10 secs |
| Article 21 – Devices for Special Purposes | 1 min 01 secs |
| Article 22 – Systems and Procedure Packs – Part 1 | 1 min 25 secs |
| Article 22 – Systems and Procedure Packs – Part 2 | 1 min 09 secs |
| Sterilization of Systems and Procedure Packs | 1 min 45 secs |
| Article 23 – Parts and Components | 1 min 33 secs |
Article 24 – Free Movement
| Article 24 – Free Movement | 1 min 23 secs |
Conclusion
Final Assessment
Certification
Author:
General Info:
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CEU Credits: 0.1 -
Course code: ELM-318 -
Duration: 60 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
If you are selling devices to the EU this course and program is a must do. The activities to be undertaken by Economic Operators before a product is placed on the market are all explained in clear concise manner.
The section on claims which impact labelling, instructions for use (IFUs) and advertising and, potentially, classification was on point and correlated exactly to the regs. Great job.
Related courses:
EU Medical Device Regulation (EU MDR) – Introduction
EU Medical Device Regulation (EU MDR) – Chapter I: Scope and Definitions
EU Medical Device Regulation (EU MDR) – Chapters 1 to 5
EU Medical Device Regulation (EU MDR) – Chapters 6 to 10
Medical Device Single Audit Program (MDSAP) – Part 1
Medical Device Single Audit Program (MDSAP) – Part 2
Medical Device Single Audit Program (MDSAP) – Part 3
ISO 13485:2016 – Chapter 1-3: Introduction
ISO 13485:2016 – Chapter 5: Management Responsibility
ISO 13485:2016 – Chapter 6: Resource Management
ISO 13485:2016 Product Realization (Chapter 7 – Part A)
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