Home beauty devices, LED masks and microneedling

• Regulation (EU) 2017/745 — MDR, including Annex XVI
• Directive 2014/35/EU — Low Voltage
• Regulation (EU) 2023/1542 — Batteries
• Regulation (EU) 2023/988 — GPSR

Who has to appoint one

Manufacturers and sellers outside the Union placing home beauty devices on the EU market. Annex XVI of the MDR brings several products without a medical purpose into the device regime, including equipment for reducing or removing adipose tissue and high-intensity electromagnetic radiation for skin treatment.

Thresholds and exemptions

Needle length decides microneedling: devices penetrating the skin barrier are invasive and treated as devices. Light-based devices are assessed against the Annex XVI common specifications.

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, electrical ratings, battery markings, and the contraindication warnings on skin type, photosensitivity and pregnancy.

Marketplace fields

Marketplaces remove devices making treatment claims without registration, and LED masks and radiofrequency devices have been the subject of targeted enforcement.

Documentation you must hold

For consumer devices, the declaration of conformity, technical file and photobiological assessment. For Annex XVI devices, full MDR technical documentation, clinical evaluation demonstrating safety, risk management and the notified body certificate, plus EUDAMED registration.

Standards and testing

IEC 62471 for photobiological safety, EN 60335 or IEC 60601 depending on classification, and for Annex XVI products the tests required by the common specifications including energy density and temperature measurement.

Language requirements

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

When it applies

Before placing on the market. The Annex XVI common specifications have applied since 2023 with transitional arrangements now largely expired.

How long records are kept

Ten years, or the MDR periods for Annex XVI devices.

What happens if you do not comply

Withdrawal, and for unregistered Annex XVI devices the finding of placing a medical device on the market without conformity assessment, which is significantly more serious than a labelling defect.

Who enforces it

Medical device competent authorities, market surveillance authorities and customs.

Where the boundary lies

Annex XVI is the decisive and least understood provision: it captures products with no medical purpose but with a similar risk profile to devices, including dermal fillers, contact lenses without corrective function, liposuction equipment and intense light devices for skin.

Questions we are asked

Does an LED face mask need a notified body?

If it falls within the Annex XVI category for high-intensity electromagnetic radiation for skin treatment, yes. The absence of a medical claim does not exempt it.

Are dermarollers regulated?

Devices that penetrate the skin are invasive and generally fall under the MDR, with classification depending on needle length and duration of contact.