The Decision adopted 26 July 2018 (in force as of 28 August 2018) provides criteria for determining how the type of a medical device constituent is to be identified.
A constituent part of a medical product could be: the main unit (part) of a medical device (product), accessory, a component of a medical product or a consumable for a medical product.
The following criteria are to be applied for the classification of a part of a medical product for the purpose of its registration:
- if the item in question is a product or material consumed when a medical device is used, then such an item will be considered as a consumable. It is possible to use another medical device as a consumable of another medical device, including a medical device that has been duly registered in the EAEU;
- if the item in question is not an article or a material that is consumed during the use of a medical device in accordance with its function and is released on the market on behalf of the medical device manufacturer and:
(a)If it is not a spare part of a medical device - then such an element will be considered the main unit (part) of the medical device; OR
(b)If it is a spare part of a medical product, then such an item is a component of a medical product;
- if the item is not a product or material that is consumed during the use of a medical device in accordance with its function and it is released on the market NOT on behalf of the item’s manufacturer but on behalf of the item’s manufacturer, while:
If it is a medical product, admitted for circulation within the framework of the EAEU and intended in accordance with the documentation of the manufacturer of the registered medical product to ensure its functioning in accordance with the purpose, such an element is considered to be the main unit (part) of the medical product;
If it is not a medical device and is specifically intended by its manufacturer for joint use with a medical device, then such an item will be considered as an accessory of the medical product;
If it is not a medical device and is not specifically intended for use by a manufacturer for the purpose of being used jointly with a medical device, then such an item is a component of the medical device.
Law: Decision No. 116 of the EAEU Commission Collegiate dated 24 July 2018 on the Criteria for the Division of Medical Device Components for Registration Purposes