Date : 11-05-27 15:00
The borderline of MDD; warming blankets
 Name : CE Manager
Hit : 559  
   version1_9_borderline_manual_en.pdf (284.4K) [1] DATE : 2011-05-27 15:00:51
Warming blankets

- Background
This matter relates to the classification of warming blankets. It concerns a manufacturer who markets warming blankets on the basis of warm air, produced by an extra warming device.
The manufacturer considers the blanket to be an accessory to the active device and as such the manufacturer considered it Class I.

- Outcome
1/ Medical device or not?
The medical purpose has to be clearly identified and substantiated to qualify these products as medical devices
2/ If the blanket and the generator are sold as a single medical device:
Classification rule 9 would classify these products as class IIa or class IIb medical devices depending on the state of the patient (which is inherently linked to different levels of risks). When the product is intended to be used on an unconscious patient (who therefore cannot remove the blanket), e.g. in reanimation services, the device is to be classified as class IIb medical device. If the device is intended to be used on a conscious patient (who therefore can react), the device is to be classified as class IIa medical device.
3/ If the blanket and the generator are sold separately:
The blanket sold separately cannot be considered as an active medical device and is a Class I medical device in accordance with rule 1.
The generator sold alone would be class IIa or class IIb in accordance with classification rule 9. The manufacturer will have to specify the use of such generator.

Refer to the attachment, version1_9_borderline_manual_en