Human Factors Testing for CE Marking of a Cosmetic Device

M

Mike in Seattle

#1
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
 
Elsmar Forum Sponsor

pkost

Trusted Information Resource
#3
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
 
M

Mike in Seattle

#4
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

Trusted Information Resource
#5
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
 
M

Mike in Seattle

#6
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
 
Last edited by a moderator:

CharlieUK

Quite Involved in Discussions
#7
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
 
M

Mike in Seattle

#8
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

Quite Involved in Discussions
#9
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
 
Thread starter Similar threads Forum Replies Date
D Is Human Factors testing mandatory for a 510(k) submission? Human Factors and Ergonomics in Engineering 16
P Human Factors / Usability validation in the time of COVID Human Factors and Ergonomics in Engineering 4
P Usability/human factors engineering requirement (standard) for IVD medical device Other Medical Device Related Standards 2
A Interesting Discussion Human Factors as Root Cause AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 13
P Global medical device human factors/usability requirement IEC 62366 - Medical Device Usability Engineering 3
P Interesting Discussion Addressing Human Factors in Corrective Action AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 23
T New EU Medical Device Regulations - Q1/2 2017 and Human Factors Other Medical Device Related Standards 10
M New MHRA guidance on Human Factors - Usability Engineering IEC 62366 - Medical Device Usability Engineering 1
L BSI White Paper on Human Factors/Usability Engineering IEC 62366 - Medical Device Usability Engineering 12
S IEC 62366 vs. FDA Human Factors Requirements Human Factors and Ergonomics in Engineering 2
Y Applying Human Factors and Usability Engineering - FDA Guidance Document 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S New Draft FDA Guidance - Human Factors & Usability Engineering for Med Device Design US Food and Drug Administration (FDA) 0
F FDA officially recognizes HE75 Human Factors Standard IEC 62366 - Medical Device Usability Engineering 8
arios FDA and Human Factors - Article to share Other US Medical Device Regulations 1
J Class II Medical Device Submission - Human Factors Study Requirements US Food and Drug Administration (FDA) 3
A Hand-Out for Human Factors Training Training - Internal, External, Online and Distance Learning 7
H Ergonomics Metrics (Measureables) - Human factors engineering Lean in Manufacturing and Service Industries 39
D Human Factors and FAR Part 145.163 'Training Program' Human Factors and Ergonomics in Engineering 9
F Human Factors & Ergonomics - FAR Part 145.163 'Training Program' - Aviation Industry Human Factors and Ergonomics in Engineering 20
H PFMEA - Looking for a table with Human Factors FMEA and Control Plans 2
A 6.4 Work Environment - Human and physical factors of the work environment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q User Requirement Specification for HR (Human Resource Management System) Manufacturing and Related Processes 1
M HR (Human Resources) based software recommendations Human Factors and Ergonomics in Engineering 2
H Human Resources Process Document Control Systems, Procedures, Forms and Templates 2
M Informational EU – Meeting minutes – Competent Authorities on Substances of Human Origin Expert Group Medical Device and FDA Regulations and Standards News 0
M Informational UK – Contingency legislation covering regulation of medicines and medical devices in a no deal scenario – Human Medicines and Medical Devices (Amendm Medical Device and FDA Regulations and Standards News 3
J Deciding between Professional Use or Lay Person IVD Test - Human fecal stool specimens Other Medical Device and Orthopedic Related Topics 1
M Informational Technology and innovation of human implants | Panel for the Future of Science and Technology (STOA) | European Parliament Medical Device and FDA Regulations and Standards News 0
J0anne Implantable Devices - The effects of surgical scaffold implanted into the human body Other Medical Device and Orthopedic Related Topics 8
M What is required to run human clinical trials in France EU Medical Device Regulations 9
M Informational USFDA Final Rule – Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices Medical Device and FDA Regulations and Standards News 0
S Nonconformance to a Note in ISO13485 clause 6.2 Human Resources Effectiveness ISO 13485:2016 - Medical Device Quality Management Systems 13
S Is Human Factor Testing required as part of Design Control Validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Sidney Vianna ISO/TS 30411:2018 Human resource management - Quality of hire metric Other ISO and International Standards and European Regulations 1
M Nanomaterials? Products based on human cell or tissue derivatives? EU Medical Device Regulations 7
S Medical Devices incorporating human tissues EU Medical Device Regulations 1
S ISO 13485 Cl. 6.2 Human Resources - Personnel working within the QMS ISO 13485:2016 - Medical Device Quality Management Systems 4
Sidney Vianna Good news! Energy demand will peak for the first time in human history! Sustainability, Green Initiatives and Ecology 1
Colin Pressure Vessels for Human Occupation (PVHO) Various Other Specifications, Standards, and related Requirements 4
H Certification for Indoor Human-Robot Collaboration Safety Positioning System Human Factors and Ergonomics in Engineering 4
T Human Error vs Technique Root Cause (Categories) Human Factors and Ergonomics in Engineering 9
Document Dame How to Monitor Suppliers for Human Trafficking AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 6
C Clinical Requirements for HO (Human Organ) Medical Devices EU Medical Device Regulations 10
K Poka-Yoke for Quantity Shortage caused by Human Error Quality Tools, Improvement and Analysis 7
O Acceptance criteria bacterial endotoxins immunosera for human use Manufacturing and Related Processes 3
Marc Personnel Department to Human Resources Department - Changes over Time Career and Occupation Discussions 1
S Human Factor Summative Study Class III Device RA Checklist wanted Human Factors and Ergonomics in Engineering 2
M Auditing Human Resources and Finance Departments ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
P GS1 NHRN AIs - Creating Barcodes for Human Product Other ISO and International Standards and European Regulations 4
N Non-conformances due to Human Error Nonconformance and Corrective Action 64
Similar threads


















































Top Bottom