Medical Device or not? MDR

[dj123]

Hi all.

Struggling to get a solid decision in my head regarding an interpretation........we a relooking at creating a evacuation mat that is used to remove patients in an emergency. The mat would be used in conjunction with an inflated lifting/transfer device only.

In terms of the MDR definition, we are leaning towards the fact that the sliding device provides no medical function so is not a medical device. However a GMDN's exists that this product could fall under:

Patient transfer sliding mat: 37163

A manual device typically in the form of an open roll mat or flat sheet designed to be used by healthcare professionals to assist in the physical movement and transfer of a patient (e.g., hospitalized, disabled, geriatric) from one place to another. The device typically has no lifting capabilities and utilizes sliding techniques to move the patient. It is typically designed using low-friction artificial fibres and intended to be slid under the patient who is then gently pushed by attending staff to glide across the surface of the device.

Any thoughts?

 

[shimonv]

Hello @dj123 ,
It does seem like a borderline classification. A couple of thoughts:
1. Medical devices are defined and classified based on the application regulation; not GMDN code.
2. In the US, a Manual patient transfer device is defined as "a device consisting of a wheeled stretcher and a mechanism on which a patient can be placed so that the patient can be transferred with minimal disturbance in a horizontal position to the stretcher." It is a class one device (self declaration). True that your mat does not have wheels but the function is the same...
3. I recommend that you look at the competition to be sure. If none of them are a medical device perhaps you can follow suit.

Good luck,
Shimon

 

[Jean_B]

In the EMDN tree ( European Medical Device Nomenclature (EMDN) ) that's under V0805, with some more specific variants existing.
The annoying thing there is that besides the title, there is no description to help.

As for your qualification you would be dealing with a (temporary) disability to mobilize themselves adequately in event of certain emergencies, and you would aid by alleviating or compensating for that disability by aided transfer through external support which prevents further unnecessary harm to them.

Class I if only intact skin; technically also Class IIa if you intend for injured skin to touch your product. However, most would probably stop at such extreme extrapolations, but keep to Class I.

MDCG 2021-24 lists as example for Rule 1 (Class I) "Devices intended in general for external patient support (e.g. hospital beds, patient hoists, walking aids, wheelchairs, stretchers, dental patient chairs... Wheelchairs pushed by hand)"

 

[dgrainger]

Hi,

Just looking at MDCG 2021- 24, it looks to have similar function as a stretcher, and would be class I by rule 1:

"Devices intended in general for external patient support (e.g. hospital beds, patient hoists, walking aids, wheelchairs, stretchers, dental patient chairs)"

I don't think Patient transfer sliding mat: 37163 matches your product though.

 

[T_Haley]

CLass 1; rule 1 for sure - taxation questions maybe if they still apply,,,