Difference between Medical Device, Accessory, Spare Part, and Consumable according to MDR

The European Medical Device Regulation (MDR 2017/745) provides clear definitions and requirements for various categories of products in the medical field. Here are the differences between medical device, accessory, spare part, and consumable according to the MDR:

Medical Device

A medical device is an instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used for human beings. These devices are designed to fulfill a medical purpose, such as diagnosis, prevention, monitoring, treatment, or alleviation of disease and injury.

Examples:

Pacemakers
X-ray machines
Blood pressure monitors

Accessory

An accessory for a medical device is an article intended specifically by its manufacturer to be used together with one or several particular medical devices to enable them to be used in accordance with their intended purpose. An accessory itself is not necessarily a medical device but supports its function.

Examples:

Electrodes for an ECG machine
Software for image analysis of X-ray devices
Adapters for surgical instruments

Spare Part

Spare parts are components used to repair or maintain a medical device. They ensure the device remains functional throughout its lifespan. Spare parts are often identical to the original parts of the device.

Examples:

Batteries for implants
Replaceable sensors for diagnostic devices
Replacement bulbs for surgical lights

Consumable

Consumables are items that are used up during the operation of a medical device and need to be regularly replaced. They are often intended for single use and are disposed of after use.

Examples:

Disposable syringes
Infusion sets
Test strips for blood glucose meters

Regulatory Requirements according to MDR

The MDR specifies specific requirements for each of these categories:

Medical Devices: Must bear a CE marking and demonstrate conformity with the essential requirements. They are subject to a risk assessment and must be regularly monitored.
Accessories: Must also bear a CE marking and are often evaluated together with the medical device for which they are intended.
Spare Parts: Must ensure they do not impair the function and safety of the medical device. Spare parts originating from the original manufacturer are subject to the same quality standards as the original device.
Consumables: Must meet essential safety and performance requirements, particularly regarding sterility and biocompatibility.

These distinctions and the associated regulatory requirements ensure that all components and materials used in medical technology meet the stringent safety and performance standards set by the MDR.

For detailed information, please visit the Official website of MDR 2017/745.