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General obligations for manufacturers of medical devices

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A manufacturer is a physical 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 trade mark.

What requirements apply to a manufacturer?

The table below lists some of the requirements, but the list is not exhaustive. The requirements that are relevant for each individual manufacturer also depend on the type of medical device and the device's risk classification. The requirements and obligations of manufacturers are found in several parts of MDR and IVDR and it is important that manufacturers familiarise themselves with the entire regulations. 

Table showing the general obligations for manufacturers of medical devices
​​Article Overview of some of the requirements​
​MDR Article 10
IVDR Article 10		 ​General obligations for: 
  • ​Risk management system 
  • Clinical evaluation (MDR) / performance evaluation (IVDR) 
  • Technical documentation 
  • Conformity assessment, EU declaration of conformity and CE marking of conformity 
  • Unique Device Identification (UDI) 
  • Registration of device and manufacturer 
  • Storage time of documentation 
  • Availability and providing of documentation 
  • Quality management system 
  • System for monitoring after the device has been placed on the market  
  • Implementation of corrective measures 
  • Notification of devices on the market that do not comply with the regulations 
  • System for recording and reporting of incidents and field safety corrective actions  
  • Registration of original manufacturer if the manufacturer has their device designed or manufactured by another enterprise 
  • Insurance / coverage for damage caused by the manufacturer's device 
​MDR Article 11
IVDR Article 11		 ​Requirement for an authorised representative for manufactureres outside the EU/EEA ​or Turkey
​MDR Article 15
IVDR Article 15		 ​Requirement for a person responsible for regulatory compliance
​MDR Article 18 ​Requirements for patient information and implant cards for implantable medical devices
​MDR Article 22 ​Requirements for systems and procedure packs
​MDR Article 29
IVDR Article 26		 ​Requirements for registration of devices
​MDR Article 31
IVDR Article 28		 ​Requirements for registration of manufacturers and single registration number
​MDR Article 32
IVDR Article 29		 ​Requirements for summary of safety and clinical performance
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