Can a hair transplant apparatus be CE-marked as medical device?

#1
It is a needle concerning Follicular unit extraction (fue) procedure for hair transplantation. I've seen some robotics used in hair transplantation have been regulated as medical device, i.e. in Canada.

However, I'm not familiar with the European approach. Could you please help me?
 
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Ronen E

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Staff member
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#2
The MDD says:

‘medical device' means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combi-nation, 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;
MEDDEV 2.1/1 section 1.1 (d):

medical - toiletry purpose

The definition of "medical device" should be understood to include products intended to be used principally for a medical use. Therefore products intended to have a toiletry or cosmetic purpose are not medical devices even though they may be used for prevention of a disease. Examples for products for which a medical purpose can normally not be established :

- tooth brushes, dental sticks, dental floss;
- baby diapers, hygiene tampons;
- contact lenses without corrective function intended to provide another colour to the eyes,
- bleaching products for teeth [needs to be further discussed with regard to products intended specifically for application by dentists]
- instruments for tattooing.

Examples for products, where depending on the circumstances, a medical purpose can be established:

- incontinence products.
 

pkost

Trusted Information Resource
#3
Although hair transplants can be for a cosmetic purpose, they are also used to treat
conditions such as allopecia and pattern baldness which are medical conditions. Therefore when devices are used to transplant hair for the treatment of these conditions they must comply with the medical device directive and be CE marked
 
#4
Hi,

The new EU MDR regulation states the following,

Page 13, paragraph 12

Certain groups of products for which a manufacturer claims only an aesthetic or another non-medical purpose but which are similar to medical devices in terms of functioning and risks profile should be covered by this Regulation. In order for manufacturers to be able to demonstrate the conformity of such products, the Commission should adopt common specifications at least with regard to application of risk management and, where necessary, clinical evaluation regarding safety.

Such common specifications should be developed specifically for a group of products without an intended medical purpose and should not be used for conformity assessment of the analogous devices with a medical purpose. Devices with both a medical and a non-medical intended purpose should fulfill both the requirements applicable to devices with, and to devices without, an intended medical purpose.

So it really depends on the claimed intended use of the product.

- If it has a medical use - then you need to follow the regulations.
- If it has a non-medical use - CS (not published yet)
- If it has both uses - Then follow both the CS and the regulations.
 

rob73

looking for answers
#5
Hi,
If the device is not currently registered to be sold in the EU, then ask the competent authority of the region it is going to be sold in for advise. i.e. in the UK it would be the MHRA.
(as a note a quick internet search showed the Hans biomed Lion hair transplanter as CE marked)
 
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