Importer and distributor
European Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices respectively define importer as any natural or legal person established in the Union who places a device from a third country on the Union market.
Distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a device available on the market by the time it is put into service.
General obligations of importers and distributors are defined in Article 13 and Article 14 of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
If an importer or distributor believes or has reason to believe that a product poses a serious risk or that it is a counterfeit product, the Federal Office for Safety in Health Care (BASG) must be contacted by e-mail at email@example.com.
Complaints and reports from healthcare professionals, patients or users about suspected incidents related to a product they have provided must be forwarded to the manufacturer and, if applicable, the authorized representative and the importer.
The European regulations specify in Article 16 cases where the manufacturer's obligations also apply to importers or distributors. In the case of relabeled or repackaged products according to Article 16, paragraph 2, the notification to the Federal Agency for Safety in Health Care (BASG) must be sent by e-mail to firstname.lastname@example.org.