Responsibilities of Distributors for collection of Medical Devices and incident reporting

The obligation of the distributors regarding the collection of Medical devices and incident reporting is described in Article 14 - General obligations of distributors points 4, 5, and 6. First of all, this means that the distributor must be available to the manufacturer for any instructions given by the manufacturer regarding a recall or incident. Next, the distributor must be ready to communicate with the competent authority and provide a sample of the product when necessary. Furthermore, if the distributor himself receives a complaint, he must immediately inform the manufacturer about it, and further act in accordance with the manufacturer's instructions.  

For more information see:

• EU MDR Article 14 - General obligations of distributors https://advisera.com/13485academy/mdr/general-obligations-of-distributors/