Domestic to Medical Device Use - Riser/Recliner Chair or a Commode

JoCam

Trusted Information Resource
#1
Hi All,

This may seem like a very silly question, but when would an item such as a riser/recliner chair or a commode become a medical device? These are supplied into domestic premises, care homes and hospitals, so is it a question of where they are being used, the needs of the end-user, who the supplier is or something else I obviously haven't considered? Perhaps they don't need to be a medical device at all, in which case I wonder why most of them are.

Thanks in advance,

Jo
 
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lewisking34

Starting to get Involved
#2
Re: Domestic to Medical Device

Hi JoCam,

This may be a very silly answer...

Are the chairs Medical Devices, or are they just CE Marked because they fall under one of the following categories?

active implantable medical devices
appliances burning gaseous fuels
cableway installations designed to carry persons
eco-design of energy related products
electromagnetic compatibility
equipment and protective systems intended for use in potentially explosive atmospheres
explosives for civil uses
hot-water boilers
household refrigerators and freezers
in vitro diagnostic medical devices
lifts
low voltage
machinery
measuring instruments
medical devices
noise emission in the environment
non-automatic weighing instruments
personal protective equipment
pressure equipment
pyrotechnics
radio and telecommunications terminal equipment
recreational craft
safety of toys
simple pressure vessels

(lifted from gov.uk/guidance/ce-marking)

KR,
Lewis
 

JoCam

Trusted Information Resource
#3
Re: Domestic to Medical Device

Hi Lewis,

I'm not sure, all I know at present is that the Riser/Recliner has not been CE marked under the MDD 93/42/EEC. This then prompted my question, should they be medical devices or not.

Jo
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Re: Domestic to Medical Device

The answer is quite simple. It depends on the intended use as determined by the legal (responsible) manufacturer.

The intended use can usually be deducted from the accompanying labelling and other promotional materials. If those are inconclusive or the object is being used in different settings / for different purposes in different places, the intended use might be determined also based on verbal statements / presentation, when marketed / sold.
 

dgrainger

Trusted Information Resource
#5
Probably not...

From MHRA Guidance on legislation Borderlines with medical devices:

5. Assistive technology products (aids for daily living)
Equipment intended for alleviation of, or compensation for a disability may or may not be considered as medical devices. The determining factor will be whether or not there is a direct link between the corrective function of the equipment and the individual concerned and that there is a stated medical purpose.
The following products are considered to be medical devices as there is such a direct link:
• baths with integral hoists
• external limb prostheses and accessories
• hearing aids
• mobility aids for the visually impaired
• orthopaedic footwear
• orthoses (lower/upper limb, spinal, abdominal, neck, head)
• patient hoists
• rehabilitation tricycles / mobility carts
• walking / standing frames
• walking sticks / crutches
• wheelchairs.​
Other products, however, will be considered as ‘general equipment’ since it may be used ‘by all’ (rather than having a direct link with the individual concerned). Such products are usually considered as ‘aids for daily living’ and are not medical devices. For example:
• acoustic signals at traffic lights
• baths with doors
• grab rails (at doorways, stairs etc)
• personal alarm systems / home alarm systems
• portable ramps
• special water taps
• stair lifts
• toilet equipment for the disabled / elderly (e.g. toilet seats, shower seats, commodes).​

MEDDEV 2. 1/1 states:

aids for handicapped persons

In the case of equipment intended for alleviation of or compensation for a handicap, there must be a direct link between the corrective function and the person concerned. Therefore the following equipment are not medical devices :
- acoustic signals at traffic lights,
- special water taps, toilet equipment for handicapped​

It all depends on the claims!
 
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