Hair dryers, straighteners and IPL devices

• Directive 2014/35/EU — Low Voltage
• Directive 2014/30/EU — EMC
• Directive 2011/65/EU — RoHS
• Directive 2012/19/EU — WEEE
• Regulation (EU) 2017/745 — MDR and Annex XVI for certain light-based devices

Who has to appoint one

Manufacturers and sellers outside the Union placing personal care appliances on the EU market. Light-based hair removal devices are a special case: Annex XVI of the MDR brings certain products without a medical purpose, including high-intensity electromagnetic radiation equipment for skin treatment, into the medical device regime.

Thresholds and exemptions

None for the electrical rules. For IPL and laser devices the Annex XVI common specifications determine whether the device is caught, and consumer IPL devices marketed for hair removal generally are.

What must appear on the label

CE marking, with the notified body number where the MDR applies. Manufacturer and EU representative details, model and batch number, rated voltage and power, the WEEE symbol, and for IPL devices the warnings on skin type, eye protection and contraindications.

Marketplace fields

Marketplaces check the EU responsible person and the WEEE number, and remove IPL devices making medical claims without a device registration. Hair dryers with detachable heating elements have been recalled repeatedly for burn and electrocution risk.

Documentation you must hold

EU declaration of conformity covering LVD, EMC and RoHS. Technical file with thermal, insulation and abnormal operation test reports. For Annex XVI devices, the full MDR technical documentation, clinical evaluation, risk management file, and notified body certificate. National WEEE and packaging registrations.

Standards and testing

EN 60335-2-23 for appliances for skin or hair care, EN 55014 for EMC, IEC 62471 for photobiological safety of light sources, and for Annex XVI devices the tests set by the common specifications, including energy density limits and skin type suitability.

Language requirements

Instructions, warnings and contraindications in the language of each member state of sale.

When it applies

Electrical documentation before placing on the market. The Annex XVI common specifications have applied since 2023, with transitional arrangements that have now largely expired.

How long records are kept

Ten years for the technical documentation, and for Annex XVI devices the MDR retention periods.

What happens if you do not comply

Withdrawal, recall and Safety Gate alerts for burn and shock hazards. For IPL devices sold without meeting Annex XVI, the finding is placing an unregistered medical device on the market, which is significantly more serious than a labelling defect.

Who enforces it

Market surveillance authorities, medical device competent authorities for Annex XVI products, WEEE registers and customs.

Where the boundary lies

A hair dryer is an ordinary appliance. A consumer IPL device is in the medical device regime through Annex XVI even though it makes no medical claim, and needs a notified body. That distinction catches many sellers who treat both as small electricals.

Questions we are asked

Does an IPL device really need a notified body?

If it falls within Annex XVI as high-intensity electromagnetic radiation equipment intended for skin treatment, yes. The absence of a medical purpose does not exempt it.

Do we need a WEEE number for a hair dryer?

Yes, in each member state you ship to, plus a packaging registration.