Aesthetic products / indication

[Ana Karoline]

Hi,

How can we define what is aesthetic indication and medical indication? Is there a database where I can see what is a medical indication?




Thanks,

 

[Marc]

Please post in English.

 

[primavesvera]

Hi,

How can we define what is aesthetic indication and medical indication? Is there a database where I can see what is a medical indication?




Thanks,

You mean, what is a medical device?

For the EU market, for the medical device, check Medical Device Regulation, because Medical Device Directive will be invalid from May 2021:

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745

Look at the scope and the definitions.

As for the cosmetic products - Regulation (EC) No 1223/2009 on cosmetic products:
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32009R1223&from=EN

These documents can be also read in the languages of the EU country members.

 

[Ana Karoline]

Hi,

How do I know if an indication is medical or aesthetic? for example:

• Treatment of Partial unilateral lentiginosis (PUL) and Post-inflammatory hyperpigmentation (PIH)
• Treatment of Atrophic or hypertrophic scars
• Treatment of Telangiectasias including spider angiomas
• Treatment of onychomycosis
• Treatment of Telangiectasia and Port wine lesions
• Improvement of scar appearance

Are these indications medical or aesthetic indications?

The device provide LASER light-based technology in the dermatology, vascular surgery, and gynecological fields.

 

[chris1price]

I suggest looking at the definition of a medical device in the references Primavesvera provided. These will refer to having a purpose of:

• Diagnosis, prevention, monitoring, treatment or alleviation of disease
• Diagnosis, monitoring, treatment, alleviation of or compensation for an injury
• Investigation, replacement, modification or support of the anatomy or of a physiological process
• Supporting or sustaining life
• Control of conception
• Disinfection of medical devices
• Providing information for medical purposes by means of in vitro examination of specimens derived from the human body and which does not achieve its primary 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 will need to consider whether the "Treatment" your laser provides performs any of these activities. I suspect most of them do as treatment of scars would fall under alleviation of an injury.

If you consider the indication to be purely aesthetic, then you should clearly justify that decision in writing, as you may have to justify it to a Notified Body or Competent Authorities.

 

[Ana Karoline]

My NB claims that these indications that I mentioned above are aesthetic, but in our understanding, they are medical ... because we use LASER to treat acne lesions , onychomycosis, for example ...

My question is whether there is a database, saying what is or is not considered a disease.

 

[Raisin picker]

Well, that database would be ICD, I guess.
You might also want to have a look at similar devices.
The exact wording of the intended use and especially the clinical benefit could also affect the decision.
That type of device seems not to be included in the borderline manual, but you might still want to have a look there to get a feeling about the concept.