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Cases in which obligations of manufacturers apply to importers, distributors or other persons

Published:

Changes

Importers, distributors or other persons will, with article 16 of MDR and IVDR, have clearer requirements when carrying out changes to packaging to a device, repackaging or other changes to medical devices.

Article 16 describes when manufacturers obligations apply, which modifications are exempted, and which requirements must be met in order for these modifications to be carried out. For additional information see guidelines and Q&A from the Commision. 

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