MEDICAL DEVICE

Any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application.

Description

A MEDICAL DEVICE is intended by the manufacturer to be used for human beings for the purpose of:

diagnosis, prevention, monitoring, treatment or alleviation of disease
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
investigation, replacement or modification of the anatomy or of a physiological process
control of conception

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

For further information on MEDICAL DEVICES, see the Medicines and Healthcare Products Regulatory Agency (MHRA) website at: Medical devices regulation and safety.

A subtype of MEDICAL DEVICE is:

MACHINE
.

Attributes

Key	Attribute Name
Key	MEDICAL DEVICE IDENTIFIER
	HIGH LEVEL CODE FOR HIGH COST TARIFF EXCLUDED DEVICE
	IMPLANT BATCH OR LOT NUMBER
	IMPLANT CATALOGUE NUMBER
	INTERNET ENABLED THERAPY INTEGRATED SOFTWARE ENGINE USED INDICATOR
	LOCAL HIGH COST TARIFF EXCLUDED DEVICE CODE
	MEDICAL DEVICE MANUFACTURER
	MEDICAL DEVICE NAME
	MEDICAL DEVICE PROCUREMENT ROUTE
	MEDICAL DEVICE QUANTITY
	MEDICAL DEVICE SERIAL NUMBER
	MEDICAL DEVICE SIZE
	SUBSIDIARY LEVEL HIGH COST TARIFF EXCLUDED DEVICE CODE

Relationships

Each MEDICAL DEVICE

Key	Relationship	Class
	must be used in one and only one	CLINICAL INTERVENTION

Where Used

Type	Link	How used
Data Set	Aggregate Contract Monitoring Data Set	references in description MEDICAL DEVICE
Data Element	CLINICAL INTERVENTION DATE (MEDICAL DEVICE IMPLEMENTATION)	references in description MEDICAL DEVICE
Data Set	Devices Patient Level Contract Monitoring Data Set	references in description MEDICAL DEVICE
NHS Business Definition	High Cost Device	references in description MEDICAL DEVICE
NHS Business Definition	High Cost Tariff Excluded Device	references in description MEDICAL DEVICE
NHS Business Definition	Implant	references in description MEDICAL DEVICE
NHS Business Definition	Internet Enabled Therapy Integrated Software Engine	references in description MEDICAL DEVICE
Class	MACHINE	references in description MEDICAL DEVICE
Class	MEDICAL DEVICE	references in description MEDICAL DEVICE
Attribute	MEDICAL DEVICE IDENTIFIER	references in description MEDICAL DEVICE
Attribute	MEDICAL DEVICE MANUFACTURER	references in description MEDICAL DEVICE
Attribute	MEDICAL DEVICE NAME	references in description MEDICAL DEVICE
Attribute	MEDICAL DEVICE PROCUREMENT ROUTE	references in description MEDICAL DEVICE
Attribute	MEDICAL DEVICE QUANTITY	references in description MEDICAL DEVICE
Attribute	MEDICAL DEVICE SERIAL NUMBER	references in description MEDICAL DEVICE
Attribute	MEDICAL DEVICE SIZE	references in description MEDICAL DEVICE
Data Set	Patient Level Contract Monitoring Data Set	references in description MEDICAL DEVICE
NHS Business Definition	Radiotherapy Machine	references in description MEDICAL DEVICE
NHS Business Definition	Remote Monitoring	references in description MEDICAL DEVICE
Data Element	UNIT PRICE (COMMISSIONER)	references in description MEDICAL DEVICE
Data Element	UNIT PRICE (SUPPLIER)	references in description MEDICAL DEVICE
Data Element	VALUE ADDED TAX CHARGED INDICATOR (CONTRACT MONITORING)	references in description MEDICAL DEVICE
Attribute	VALUE ADDED TAX CHARGED INDICATOR FOR CONTRACT MONITORING	references in description MEDICAL DEVICE

Also Known As

This class is also known by these names:

Context	Alias
Plural	MEDICAL DEVICES