Module 17 2024

Howard Dobbs

04/12/2024

General obligations of Manufacturers, Distributors and Importers Articles 10, 13 and 14

• Manufacturers must comply with the requirements of Article 10 • Distributors must comply with the requirements of Article 13 • Importers must comply with the requirements of Article 14

13

The Organisation for Professionals in Regulatory Affairs

Howard Dobbs

13

MDR Article 16.2 Allowed modifications

• The following are not considered to be modifications of a device already placed on the market or put into service: a) Provide a new label and a new IFU (e.g. translate existing information) b) Change the outer packaging of the device provided repackaging is necessary in order to market the device in the relevant Member State and provided the repackaging is carried out in such a way that the original condition of the device is not affected. • In other words , the distributor or importer is allowed to relabel and repack without assuming the obligations of the manufacturer . This is true unless you open the sterile packaging.

14

The Organisation for Professionals in Regulatory Affairs

Howard Dobbs

14

<#>

7