Human Factors Testing for CE Marking of a Cosmetic Device

[Mike in Seattle]

We are developing an Intense Pulsed Light-based hair removal system for home-use (not professional use), which is considered to be a cosmetic product in the European Economic Area. We wish to seek CE marking. I have a question which I am unable to answer after reviewing all of the applicable Directives and Guidelines governing cosmetic products in the EEA. The question is this: Is it necessary to perform human factors testing (usability testing) on the above mentioned product in order to gain CE marking?

Thank you for sharing your wisdom!

Mike in Seattle

 

[Stijloor]

A Quick Bump!

Can someone help Mike?

Thank you very much!!

 

[pkost]

Hi,

I do not believe light based systems are classified as cosmetic products; the regulation (EC 1223-2009) states:

This Regulation establishes rules to be complied with by any cosmetic product made available on the market.....

‘cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body

A light source is neither a substance or mixture.

Additionally, in the EU cosmetic products are not CE marked.

You may want to consider these directives, which do require CE marking (please note I have no experience with any of these - I'm guessing by looking at titles)
- Electromagnetic compatibility
- Low voltage
- machinery

If any aspect of your product (such as glasses to protect eyes from the light source) offers protection then you will need to consider the PPE directive (another CE marking directive)

Although it doesn't currently apply and may not for a number of years, you may want to keep abreast of the Medical device regulation changes as that is currently stating that "Intense pulsed light equipment" for cosmetic use shall be considered a medical device. Please note however that this is not currently in force and you cannot use this draft regulation to apply a CE mark

 

[Mike in Seattle]

Thank you very much for your reply ? it is helpful, and I appreciate it.

I have confirmed that Intense Pulsed Light (IPL) hair removal products are considered to be cosmetics in the EU ? and there are several such products on the market there that are CE- marked. You are exactly right, the Electromagnetic Compatibility and Low Voltage Directives apply to the subject product. I have confirmed this, as well. I will further consider the machinery and PPE Directives ? thank you, good advice. You are also correct regarding the potential future reclassification of IPL hair removal, home-use products into the medical device category.

My immediate question, however, is this: Is a Human Factors (Usability) study necessary for CE marking of the subject product?

I appreciate your earlier reply.

All the best.

Mike

 

[pkost]

Hi,

I am almost 100% certain that IPL is not considered a cosmetic product under the comsetic regulation even though it has a cosmetic intended use. This is in the same way that dermal fillers are not covered by the cosmetic regulation and neither is liposuction equipment.

I'm afraid I can't offer any advice of EMC/LVD directives and whether they require useability studies although I believe that there are others on this forum who can

 

[Mike in Seattle]

Greetings,

Again, thank you very much for your input. I will revisit the product classification.

Perhaps there are others in the forum that can help with the Human Factors (Usability) study requirement question.

All the best.

Mike

 

[CharlieUK]

Commenting specifically on EMC and LVD (and not on cosmetics/medical):

Human Factory testing, per se, is not required for these Directives, but:

- EMC testing should consider normal operation modes, expected normal operation and expected/acceptable temporary degradation in performance due to certain immunity phenomena

- Safety testing again has to consider normal operation and, to a certain extend, foreseeable misuse. Product labelling and/or User Instruction must provide instruction on safe use and warn against unsafe/dangerous use.

More detail of these areas is contained within the relevant EMC and Safety standards

Charlie

 

[Mike in Seattle]

Thank you very much Charlie. Your comments are very helpful. Thus far, I find no statutory or regulatory (including guidance documents) requirements for conducting Human Factors (Usability) testing for the subject product.
I would still welcome additional comments regarding this matter from other forum participants.
Best regards,
Mike

 

[CharlieUK]

Mike

By all means, gather plenty of opinions from here, but as a manufacturer you also conduct your own review of the requirements - i.e. read the Directives and the "official" guidance documents and document what you have, and have not, done in your Technical File as Due Diligence

Charlie

 

[Mike in Seattle]

Thank you kind sir.

Mike