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General obligations for authorised representatives of medical devices

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Authorised representative is 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.

What requirements apply to an authorised representative?

The table below lists some of the requirements, but the list is not exhaustive. Requirements and obligations for authorised representatives are found in several parts of MDR and IVDR and it is important that authorised representatives familiarise themselves with the entire regulations.​

Table showing general obligations for authorised representatives of medical devices
Article​​ ​​Overview of some of the requirements
​MDR Article 11
IVDR Article 11

​General requirements for:

  • ​Mandate from the manufacturer
  • Control of
    • ​EU Declaration of conformity
    • Technical documentation  
    • The conformity assessment procedure 
    • The manufacturer’s registration and UDI  
  • Cooperate with the competent authorities by
    • ​Make documentation available 
    • Assist in making devices or samples available  
    • ​Implement preventive or corrective measures  
  • ​​Registration of an authorised representative 
  • Inform the manufacturer immediately about complaints and reports of incidents 
  • If the manufacturer acts contrary of its obligations 
    • ​Terminate the mandate with the manufacturer 
    • Inform the Norwegian Medical Products Agency and the notified body 

An authorised representative, together with the manufacturer, is legally responsible for defective devices. 
​​MDR Article 11
IVDR Article 11		 ​Requirements for replacing an authorised representative
​​MDR Article 15
IVDR Article 15		 ​Requirement for person responsible for regulatory compliance
​​MDR Article 31
IVDR Article 28		 ​Requirements for registration of authorised representatives and single registration number
​​MDR Article 95
IVDR Article 90

​Requirement for procedure for dealing with devices presenting an unacceptable risk to health and safety
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