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General obligations for importers and distributors of medical devices

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Importer: The one bringing devices from a third country into circulation within the EU. Distributor: Any in the sales chain, aside from the manufacturer or importer, making devices available on the market up until the point of putting into service.

What requirements apply to importers and distributers?

​​In the table below some of the obligations for importers and distributors are listed. The list is not complete. Requirements and obligations for economic operators are found several places in MDR and IVDR. It is important that importers and distributors familiarize themselves with all the regulations that are relevant to their role.​ Se also MDCG 2021-27 rev 1 Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746

Table showing general obligations for importers and distributors of medical devices
​​Article ​​Overview of some of the obligations ​Importer ​​Distributor

MDR Article 10a

IVDR Article 10a 

Pass on information from the manufacturer regarding anticipated interruption in supply of a device to the next link in the supply chain.

This means any other economic operators, health institutions and healthcare professionals to whom they directly supply the device. 

 ü ü

​MDR article 13 and 14

IVDR article 13 and 14 ​​
 ​Obligations for control of:
  • ​Manufacturer
  • Authorised representative
  • Registration of devices ​
 ü ​
​
Obligations for control of:
  • ​Declaration of Conformity ​
  • CE marking of Conformity
  • Labelling and instruction for use
  • UDI-code 
 ü ü
​ ​Indicate on the device, packaging or accompanying document: ​
  • Importers name and adress.​​
 ​ü ​
​ ​​Verify that the device, packaging or accompanying document identify:   
  • Importers name and adress. 
 ​ ​ü
​ ​If the device is not in conformity with the regulations: 
  • ​Withdraw or recall
  • Inform manufacturer, authorised representative and importer
  • Inform the Norwegian Medical Products Agency if the device presents a serious risk or is a falsified
 ​ü ​ü
​ ​Ensure that a register is kept of complaints, of non-conforming devices and of recalls and withdrawals. ü ü
​ ​Ensure that information regarding complaints, of non-conforming devices and of recalls and withdrawals are passed on.​ ​ü ü
​ ​Ensure that necessary corrective actions are taken. ​ü ü
​ ​Ensure proper storage and transport conditions of the device. ü ü

​​MDR article 25

IVDR article 22
 ​​Ensure identification of the device within the supply chain. ​ü ​ü

​MDR article 27

IVDR article 24
 ​Ensure to store and keep the UDI  for devices where relevant. ​ü ​ü

​MDR artikkel 30

IVDR artikkel 27
 ​Verify that manufacturer or authorised representative within two weeks of placing a device have been registered. ​ü ​

​MDR article 31​​

IVDR article 28
 ​Registration of importer. ü ​
Overview of the different roles of economic operators:

 

Table showing the definition in MDR and IVDR of different roles of an economic operator
Economic operator

Definition in M​DR Article 2 and IVDR Article 2​
​Manufacturer ​A natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark.
​Authorised representative ​Any natural or legal person established within the Union* who has received and accepted a written mandate from a manufacturer, located outside the Union*, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation.
​Importer ​Any natural or legal person established within the Union* that places a device from a third country on the Union* market.
​Distributor ​Any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service.
Health institution​ ​An organisation the primary purpose of which is the care or treatment of patients or the promotion of public health.
*«Union» in this context means countries in the EU/EEA and​ Turkey.  
 
Figure: Economic operators in the supply chain.
 

EU regulations on medical devices