Why are some EMS machines not certified under MDD

[Ladybird001]

Hi,

How do some of the electronic muscle stimulators get away with not being certified under the medical device directive. I'm currently looking into the possibility of launching a new electronic muscle stimulator, similar to Sixpad. From everything I can find online I need to the get the product certified under MDD, but I have been informed that Sixpad are just CE without a Notified Body. Our product is just for fitness and we are not stating any medical benefits, just an aid to tone muscle. Can someone explain if there is a difference?
Thanks

 

[shimonv]

Hi Ladybird001,
With some products there is a very fine line between a medical device and a non-medical device. Your is one of those devices...

Below is the definition for a medical device as per the MDD:
"‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of or compensation
for an injury or handicap,
— investigation, replacement or modification of the anatomy or of
a physiological process,
— control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;"

You need to study it carefully and see if you fit the description. If not, than you are not a medical device. In one way it makes your life easy but it also puts marketing restrictions on what you can say.

Another example of sport devices that are not classified as medical device would be Heart Rate monitors. It has the potential of becoming a medical device if the manufacturer chooses to go that path, but in most cases they didn't, i.e. they made no claims relating the diagnosis, monitoring, treatment, etc.; they only display information about the heart rate.

On the other hand, if your product has proven benefit in terms of prevention or treatment and you want to take the advantage and responsibility that goes with it, than most likely you need to abide by the medical device directive.

Cheers,
Shimon

 

[Ronen E]

Hello Ladybird and welcome to the Cove

In addition to what Shimon wrote, please also consider that a product might be classified as a medical device and be CE marked without a notified body number if it falls in Class I, non-sterile and non-measuring. I'm not saying that this is the case here, just highlighting the possibility.

 

[Ladybird001]

Thank you all for your help - I think we hire the services of a specialist agency to help us through this process.