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Module 2: EU MDR 2017/745 - Chapter II - Making Available on the Market
First Section
Overview
What we have learned so far
Module II - Introduction
Course Objectives
Articles 5 - 9
Article 5 - Placing on the market and putting to service
Article 6 - Distance Sales
Article 7 - Claims
Article 8 - Use of Harmonized Standard
Article 9 - Common Specifications
Intermediate Quiz
Articles 10 - 17
Article 10 - General obligations of manufacturers
Article 11 - Authorized representative
Article 12 - Change of Authorized Representative
Article 13 - General Obligations of Importers
Article 14 - General Obligations of Distributors
Article 15 - Person Responsible for Regulatory Compliance
Article 16 - Cases in which obligations of manufacturers apply to importers, distributors or other persons
Article 17 - Single-use Devices and their Reprocessing
Intermediate Quiz
Articles 18 - 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
Article 21 - Devices for Special Purposes
Article 22 - Systems and Procedure Packs
Intermediate Quiz
Articles 23 & 24
Article 23 - Parts and components
Article 24 - Free Movement
Intermediate Quiz
Final Quiz
Quiz - Part 1
Quiz - Part II
Quiz - Part III
Article 13 - General Obligations of Importers
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