Hi Community,
My company is selling various single-use accessories (consumables) such as plastic tips in different sized (all Class I). Some of these are medical device accessories. These accessories are packed and offered for sale in various configurations. This creates quite a lot of confusion regarding how to properly label them.
1. When the an accessory is sold on its own e.g., in 50 pcs bag it is easy to handle since we just label and CE-mark the bag as 1 device (with 50 pcs unit if use).
2. We also sell some assortment boxes that contain a different plastic tips in different sizes. The plastic tips will not be in their original packaging so we decided to label and CE-mark the entire box as 1 device. The situation resembles what is described in MDR Article 22(4) although the box is not a procedure pack. We consider this acceptable.
3. The biggest challenge comes when we offer for sale a configuration containing both medical devices and non-medical products. The configurations would not fall under the definition of procedure packs.
3a. It is my understanding that if the configuration contains both medical devices and non-medical devices then we have to add the medical devices in their original package (CE-marked and properly labelled). The box containing the labelled MDs and the non-MDs would then be considered some sort of shipping box - is this acceptable? I don't think we can CE-mark the entire box as 1 device because it contains non-MDs that are not compliant the the MDR.
I am interested to understand how other are handling different sales configurations.
BR,
Pete
My company is selling various single-use accessories (consumables) such as plastic tips in different sized (all Class I). Some of these are medical device accessories. These accessories are packed and offered for sale in various configurations. This creates quite a lot of confusion regarding how to properly label them.
1. When the an accessory is sold on its own e.g., in 50 pcs bag it is easy to handle since we just label and CE-mark the bag as 1 device (with 50 pcs unit if use).
2. We also sell some assortment boxes that contain a different plastic tips in different sizes. The plastic tips will not be in their original packaging so we decided to label and CE-mark the entire box as 1 device. The situation resembles what is described in MDR Article 22(4) although the box is not a procedure pack. We consider this acceptable.
3. The biggest challenge comes when we offer for sale a configuration containing both medical devices and non-medical products. The configurations would not fall under the definition of procedure packs.
3a. It is my understanding that if the configuration contains both medical devices and non-medical devices then we have to add the medical devices in their original package (CE-marked and properly labelled). The box containing the labelled MDs and the non-MDs would then be considered some sort of shipping box - is this acceptable? I don't think we can CE-mark the entire box as 1 device because it contains non-MDs that are not compliant the the MDR.
I am interested to understand how other are handling different sales configurations.
BR,
Pete
