Massage guns, TENS units and wellness devices

• Directive 2014/35/EU — Low Voltage
• Regulation (EU) 2017/745 — Medical Devices where a medical purpose exists
• Regulation (EU) 2023/1542 — Batteries
• Regulation (EU) 2023/988 — GPSR

Who has to appoint one

Manufacturers and sellers outside the Union placing massage and stimulation devices on the EU market. A percussion massager marketed for muscle relaxation is a consumer product. A TENS or EMS device intended for pain relief or muscle rehabilitation is a medical device.

Thresholds and exemptions

None. Electrical stimulation devices are generally medical devices; mechanical massagers usually are not, unless therapeutic claims are made.

What must appear on the label

CE marking, manufacturer and EU representative details, model and batch number, rated power, battery markings, the WEEE symbol, and contraindication warnings including use with pacemakers and during pregnancy for stimulation devices.

Marketplace fields

Marketplaces remove listings claiming treatment of pain, injury or medical conditions where the product is not a registered device, and this category has attracted repeated sweeps.

Documentation you must hold

EU declaration of conformity and technical file for consumer products; MDR technical documentation, clinical evaluation and notified body certificate where the device is medical. Battery, WEEE and packaging registrations.

Standards and testing

EN 60335 or IEC 60601 depending on classification, IEC 62133 for the cell, vibration and temperature testing for percussion devices, and output measurement for stimulation devices.

Language requirements

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

When it applies

Before placing on the market.

How long records are kept

Ten years, or the MDR periods where the device is medical.

What happens if you do not comply

Withdrawal and fines, and for unregistered medical devices a substantially more serious finding. Injuries from high-torque massage guns have produced recalls.

Who enforces it

Market surveillance authorities, medical device competent authorities and WEEE registers.

Where the boundary lies

The marketing decides. 'Relaxes muscles after exercise' is a consumer claim. 'Relieves chronic pain' or 'treats sciatica' is a medical purpose that requires MDR compliance, and authorities read the whole listing including reviews the seller has solicited.

Questions we are asked

Is a TENS unit a medical device?

Yes, transcutaneous electrical nerve stimulation for pain relief is a medical purpose, so the MDR applies with a notified body for most classes.

Can we say our massage gun helps recovery?

General wellbeing claims are usually acceptable; therapeutic claims about injury or disease are not, and they change the regime entirely.