Procedure pack

Under EU MDR Article 22, whoever combines CE-marked devices into a procedure pack makes a statement instead of acting as manufacturer, as long as the products stay within their intended purposes. Including products without CE marking, or combining them outside their intended purpose, makes the pack a device in its own right.

‘procedure pack’ means a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose;

EU MDR, Article 2(10)