Clinical Evaluation for Class I Medical Devices , needed?

F

FilipeF

#1
Hi All!

I'm working for a company that is basically a textile one, producing elastic elbows, elastic self regulating wrists, elastic thighs, elastic knees, hosiery, etc, which are basically used to provide comfort when one has an injury.

One thing that we have been trying to find out is
a) Are these Medical Devices?
b) Do we need a Clinical Evaluation? :mg:

One thing, as far as we have searched, there is no literature regarding this issue..

Can anyone please share their opinion?

Thanks!!!
 
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M

MIREGMGR

#2
How do these products "provide comfort"? Control swelling, provide mechanical support in the event of a dislocation or tear, provide thermal insulation and thus increased temperature in the injured zone...? Are they used specifically to prevent further injury? Are they either prescribed or fitted by a professional?
 
F

FilipeF

#3
Hi Miregmgr. Thank you for your feedback.

It's indeed a good question what you are asking...

They do provide mechanical support, being used when you sprain for example, a wrist.
An image is better than a thousand words.. Here are some examples of alike-products I browsed the internet for:

Elastic Wrist: http://www.skyecomfort.com/mods/Products/itemimg/ts_wrist_hand.jpg
and http://www.braceshop.com/productcart/pc/Therall-Joint-Warming-Wrist-Support-58p1280.htm

Wrist: http://www.braceshop.com/productcart/pc/Cho-Pat-Wrist-Support-58p646.htm (ours has a velcro so you can fit at your size)

Thigh: http://www.eshoprx.com/thigh-band.aspx (ours has a velcro so you can fit at your size)

Lumbar Support: http://www.skyecomfort.com/mods/Products/itemimg/ts_ap_rigid.jpg

Elastic Ankle: http://www.skyecomfort.com/mods/Products/itemimg/elastic_ankle.jpg

Elastic Knee: http://www.skyecomfort.com/mods/Products/itemimg/elastic_knee.jpg

Back Stabilizer: http://www.skyecomfort.com/mods/Products/itemimg/elastic_back_stabilizer.jpg

Elastic Elbow:http://www.skyecomfort.com/mods/Products/itemimg/ts_elbow.jpg

Ours are very similar, though without the special heat-retaining fibers.
The goal is to apply some compression when you sprain something.

Doctors or pharmacists generally advise patients to buy some in case of need, or people can just go and buy them freely at any pharmacy.

I still have doubts these can be considered MD according to the EU Directive, what are your thoughts on this matter?

Thank you
 
S

SteveK

#5
Hi Filipe,

Under the UMDNS (Universal Medical Device Numbering System) - see www.ecri.org, there are a number of descriptions of bandages (i.e. medical devices) which could cover your products:

e.g.
Bandages, compression/support (UMDSN 10284)
Bandages, tubular (UMDNS -17085)
Bandages, stockinette (UMDNS 10289)
Etc

Steve
 
F

FilipeF

#6
teomanalpay: Of course... I think you're right... believe the intended use is the key for MD classification.. Our products are very simple ones, but the Directive should apply...

SteveK: Thanks! It's always good to have a comparison of similar products

I'm having a hard time on the clinical evaluation part. Is there a way through risk management that we can bypass clinical evaluation?

Or maybe by demonstrating that in 30 years there hasn't been a complaint related to health issues caused by these products?

Thanks!
 
S

SteveK

#7
Hi again Filipe,

See the attachment I previously posted (if not already seen) to show how I structure my Clinical Evalution (there should be a section in a device TF). Then you just have to widen your search (I've recommended google books as a source of info before - there must be some medical text books which reference the use of your type of products).

Just a quick search and I found a reference to the use of elbow bandages in a clinical environment i.e. their use is known - that is a start.

http://www.ncbi.nlm.nih.gov/pubmed/9814930

Steve
 

Attachments

F

FilipeF

#8
Hi steve,

Thanks a lot, I'd already seen your document, but in blank. With an example it's way easier to understand.

I've done a quick search on google books (great tip by the way) and found some great compression documents. As soon as I analyse them I'll post

Thanks again!
 
M

MIREGMGR

#9
To address your original question A:

If a device's use generally prevents excessive swelling subsequent to an injury and consequential soft-tissue and biomechanical health problems, and aids in healing by providing mechanical support and thermal insulation, then in my view it is a device per

...purpose of:[FONT=TimesNewRoman+25][FONT=TimesNewRoman+25]
[/FONT]
[/FONT][FONT=TimesNewRoman+20][FONT=TimesNewRoman+20]
—​
[/FONT]​
[/FONT]diagnosis, prevention, monitoring, treatment or alleviation of
disease,

[FONT=TimesNewRoman+20][FONT=TimesNewRoman+20]
—​
[/FONT]​
[/FONT]diagnosis, monitoring, treatment, alleviation of or compensation

for an injury or handicap,
(...)

 
F

FilipeF

#10
SteveK, a great thanks for your example of a Clinical Evaluation. I used it subjected it to the official authority and everything went well!!
 
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