Hitec Medical MDR training – Definition of MDR Terms

Medical device

It refers to any instrument, equipment, appliance, software, implant, reagent, material, or other item used solely or in combination by a manufacturer for one or more specific medical purposes in the human body:

• Diagnosis, prevention, monitoring, prediction, prognosis, treatment or remission of diseases;
• Diagnosis, monitoring, treatment, relief, and compensation for injuries or disabilities;
• The study, substitution, and regulation of anatomical, physiological, or pathological processes or states;
• Provide information through in vitro testing of samples from the human body, including organs, blood, and donated tissues;
• Its utility is mainly obtained through physical and other means, not through pharmacology, immunology, or metabolism, or although these methods are involved, they only play an auxiliary role;
• Devices with control or support purposes
• Specially used for cleaning, disinfecting, or sterilizing instruments.

Active device

Any device that operates as an energy source other than relying on the human body or gravity, and functions by changing the density of energy or converting energy. Devices used for transmitting energy, substances, or other elements between active devices and patients without any significant changes shall not be considered active devices.

Invasive device

Any device that penetrates the human body through natural channels or surfaces.

Procedure pack

A combination of products packaged together and marketed for specific medical purposes.

Manufacturer

A natural or legal person who manufactures or fully refurbishes a device or a device designed, manufactured, or fully refurbished and sells the device under its name or trademark.

Fully refurbishing

Based on the manufacturer’s definition, it refers to the complete refurbishment of devices that have been put on the market or put into use, or the use of used devices to manufacture new devices that comply with this regulation and give the refurbished devices a new lifespan. 

Authorized Representative

Any natural or legal person identified within the EU who receives and accepts written authorization from a manufacturer located outside the EU to take all actions on behalf of the manufacturer in accordance with the obligations imposed by this Regulation on the manufacturer.

Importer

Any natural or legal person identified within the European Union who places devices from third countries on the EU market.

Distributors

Any natural or legal person in the supplier, other than the manufacturer or importer, may place the device on the market until it is put into use.

Unique Device Identification (UDI)

A series of numerical or alphanumeric characters created through internationally recognized device identification and coding standards, allowing for clear identification of specific devices on the market.