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European Union
When buyers see "CE" on aesthetic equipment, they often assume one thing. There are actually two completely separate CE pathways â one for general consumer electrical products (which we comply with), and one for medical devices (which is a different regulatory category). This page explains the difference and which one applies to your import.
Low Voltage Directive â all electrical
Electromagnetic Compatibility Directive
Medical Device Regulation 2017/745
Different documentation behind it
CE marking demystified
Side by side
| Feature | Medical CE (MDR) | Cosmetic CE (LVD/EMC) |
|---|---|---|
| Regulatory basis | EU MDR 2017/745 | LVD 2014/35/EU + EMC 2014/30/EU |
| Certifying body | EU Notified Body audit | Manufacturer self-declaration |
| Required documentation | Clinical evaluation + risk management + post-market surveillance | Technical documentation + Declaration of Conformity |
| Time to issue | 12â24 months | Weeks (manufacturing compliance) |
| Cost | âŦ50,000â500,000+ depending on class | Manufacturing-level only |
| Sales channel | Often prescription / clinical-only | General professional and consumer |
| Our current range | Not applicable | â Where we sit |
Which CE applies?
Is the equipment marketed for diagnosis or treatment of disease?
Are therapeutic claims made (treating a medical condition)?
Is it sold as cosmetic enhancement only (no medical claims)?
Is it sold to general public / aesthetic salons?
Is it used by licensed medical professionals only?
Does the supplier provide an MDR-specific Declaration of Conformity?
Does the supplier provide LVD + EMC Declaration of Conformity?
Deep dive
The EU separates medical devices from general consumer products because the risk profiles, evidence requirements, and post-market surveillance obligations are fundamentally different. A medical device that fails can cause serious harm; a cosmetic device that fails is a consumer-protection issue. The two regulatory frameworks reflect this difference.
The CE mark itself certifies that the product complies with the applicable directives â not "all EU regulations" or "medical certification". Reading the Declaration of Conformity is the only way to know which directives apply. A CE-marked product without an explicit MDR reference is, by default, certified under general electrical safety, not as a medical device.
Your customs broker and the destination Member State authority care about which CE pathway the equipment uses, because the import classification differs. Cosmetic-equipment CE under LVD/EMC clears under standard consumer-product import procedures. Medical-device CE under MDR may trigger additional notifications and operator licensing in the destination country.
By directive
Low Voltage Directive 2014/35/EU covers electrical equipment between 50V and 1000V AC. Applies to virtually all aesthetic equipment. Requires technical documentation, risk assessment, and Declaration of Conformity. Self-certified by manufacturer.
Common misunderstandings
Wrong. CE under LVD + EMC is the standard pathway for cosmetic equipment. It does not mean medical-grade.
Wrong. CE applies to EU/EEA. Equipment for other markets has equivalent pathways (UKCA, FCC, KC, PSE, RCM, SASO etc.).
Misleading. FDA (US) and CE (EU) are different regulatory frameworks for different markets. Holding both is rare and reserved for medical-device companies.
Wrong. CE Declaration of Conformity is valid as long as the product and applicable directives remain unchanged. Major directive revisions (like EU MDR 2017) require re-certification.
CE marking FAQ
Yes â on request. Our Declaration covers LVD 2014/35/EU + EMC 2014/30/EU + RoHS 2011/65/EU for general consumer electrical product safety. It does not cover EU MDR (medical device) â our current range is positioned as cosmetic equipment.
We can send LVD + EMC + RoHS Declaration of Conformity and technical documentation for your specific product. We cannot provide MDR documentation we do not currently hold.