Mobility aids, wheelchairs and care equipment

• Regulation (EU) 2017/745 — Medical Devices
• Regulation (EU) 2023/1230 — Machinery for powered equipment
• Directive 2014/35/EU where electrical
• Regulation (EU) 2023/1542 — Batteries

Who has to appoint one

Manufacturers outside the Union placing mobility and care equipment on the EU market. Most of these products are Class I medical devices, and powered wheelchairs and patient lifts are higher class or additionally machinery.

Thresholds and exemptions

None. Class I devices still require technical documentation, a declaration of conformity, EUDAMED registration and an authorised representative for non-EU manufacturers.

What must appear on the label

CE marking with the notified body number where applicable, manufacturer and EC REP details, UDI, serial number, the maximum user weight, and the instructions for use including transfer and transport guidance.

Marketplace fields

Public procurement and reimbursement systems require the device registration, and marketplaces remove mobility products lacking the EC REP details.

Documentation you must hold

MDR technical documentation, clinical evaluation appropriate to the class, risk management, post-market surveillance plan, EUDAMED registration and the Article 11 mandate. For powered equipment, the machinery risk assessment and battery documentation.

Standards and testing

EN 12183 and EN 12184 for manual and powered wheelchairs, EN ISO 10535 for patient hoists, EN 60601 for electrical medical equipment, and IEC 62133 for batteries.

Language requirements

Instructions for use in the language required by each member state, which for care equipment used by non-professionals is strictly enforced.

When it applies

Registration and documentation before placing on the market.

How long records are kept

Ten years under the MDR.

What happens if you do not comply

Withdrawal and prohibition of sale, with the authorised representative sharing liability for defective devices under Article 11(5). Reimbursement bodies also delist non-compliant products, which ends the market access.

Who enforces it

Medical device competent authorities, market surveillance authorities and reimbursement bodies.

Where the boundary lies

Mobility scooters straddle regimes: some are medical devices, others are vehicles subject to national road rules, and a few are both. Powered patient lifts are simultaneously devices and machinery, requiring both risk assessments.

Questions we are asked

Is a walking stick a medical device?

Generally yes, a Class I device, which still requires documentation, registration and an EU authorised representative for a non-EU manufacturer.

Do we need a notified body for a manual wheelchair?

Class I devices are self-declared unless sterile, measuring or reusable surgical. Powered chairs are usually higher class and need one.