How to ensure that electric wheelchairs meet the CE certification requirements in Spain
I. Introduction
As one of the important member states of the European Union, Spain has strict access requirements for electric wheelchair products. CE certification is a necessary condition for electric wheelchairs to enter the Spanish market. It is not only a symbol of product safety, but also the key for companies to gain market recognition. With CE certification, electric wheelchairs can ensure free circulation in Spain and the entire EU market, providing users with safe and reliable product guarantees.
II. Background and importance of CE certification
CE certification is a mandatory requirement for product safety under EU law, which aims to ensure that products meet EU standards in terms of health, safety and environmental protection. For electric wheelchairs, CE certification is particularly important because, as a medical device product, it is directly related to the health and quality of life of the user. Electric wheelchairs that pass CE certification can not only enter the Spanish market, but also gain market competitiveness and customer recognition.
III. Applicable standards for CE certification of electric wheelchairs
CE certification of electric wheelchairs is mainly based on the EN 12184 standard, the full name of which is “Requirements and test methods for electric wheelchairs, electric scooters and their battery chargers”. The EN 12184 standard applies to electric wheelchairs with a maximum speed of no more than 15km/h, and specifies the specific requirements and test methods for the product.
(I) Mechanical safety performance
The EN 12184 standard sets strict requirements for the mechanical safety performance of electric wheelchairs, including tests such as static stability, dynamic stability, gradeability, and braking performance. These tests ensure that the wheelchair can remain stable under different road conditions, prevent tipping over or loss of control, and ensure the safety of the user.
(II) Electrical safety requirements
The electrical safety of electric wheelchairs is extremely important. The EN 12184 standard sets strict specifications for electrical components such as motors, controllers, and wiring, including waterproof level, insulation performance, overload protection, etc. In addition, the battery and charging system must also meet relevant requirements, such as the battery fixing method, charge and discharge protection, and charger safety standards.
(III) Electromagnetic compatibility (EMC)
Electromagnetic compatibility is one of the important contents of the CE certification of electric wheelchairs. The EN 12184 standard requires that electric wheelchairs can work normally in an electromagnetic environment and do not interfere with other equipment. This means that the wheelchair needs to pass radiated interference and immunity tests to ensure that it remains reliable in complex electromagnetic environments.
(IV) User control interface
The design of the user control interface directly affects the ease of use and safety of the electric wheelchair. The EN 12184 standard requires that the operating device layout is reasonable and the emergency stop function must be prominent and easy to trigger. This helps users take quick action in an emergency to avoid accidents.
IV. CE certification process
To ensure that the electric wheelchair meets the CE certification requirements in Spain, a strict certification process needs to be followed.
(I) Product classification
First, it is necessary to confirm the classification of the electric wheelchair as a medical device. According to the EU Medical Device Regulation (MDR), electric wheelchairs are generally classified as Class IIa medical devices. This classification determines the subsequent certification path and requirements.
(II) Technical document preparation
The technical document is the core part of the CE certification and requires detailed records of the product’s design, manufacturing and testing process. The technical document should include design drawings, risk analysis reports, test reports, clinical evaluations, etc. These documents need to prove that the electric wheelchair complies with relevant standards and technical regulations.
（III）Conformity assessment
Conformity assessment is usually conducted by a notified body, such as TÜV, SGS, etc. The notified body will review the technical documents and test the product to ensure that it meets the requirements of the EN 12184 standard. The test content includes mechanical properties, electrical safety, electromagnetic compatibility, etc.
（IV）Signing the Declaration of Conformity (DoC)
Once the product passes the conformity assessment, the manufacturer needs to sign the Declaration of Conformity (DoC) to declare that the product complies with the relevant EU directives and standards. DoC is an important document for the product to obtain CE certification and must be provided with the product.
（V）Affixing the CE mark and registering
After completing the above steps, the manufacturer can affix the CE mark to the product and register it in the EUDAMED database through the EU authorized representative. The CE mark is a pass for the product to enter the EU market, and the EUDAMED registration ensures the traceability of the product.
V. Common non-conformities and solutions
During the CE certification process, electric wheelchairs may have some non-conformities. The following are common problems and solutions.
1. Electrical safety is not up to standard
Electrical safety is one of the common problems in CE certification of electric wheelchairs. Solutions include using electrical components with IPX4 and above protection levels to ensure the waterproof performance of the circuit. In addition, the circuit needs to be designed with overload protection to prevent safety hazards caused by short circuit or overload.
2. Failure of stability test
Failure of stability test may be due to unreasonable center of gravity design of the wheelchair or insufficient anti-roll wheels. Manufacturers can improve the stability of the product by adjusting the center of gravity position or adding anti-roll wheels.
3. Key information is missing from the manual
The manual is an important part of the product and must include multilingual versions and illustrated instructions. Manufacturers should ensure that the manual is detailed
Post time: Jul-18-2025