What are the requirements for exporting electric wheelchairs to the EU?

What are the requirements for exporting electric wheelchairs to the EU?

Exporting electric wheelchairs to the EU market requires meeting a series of strict requirements and standards. The following are detailed steps and requirements:

I. Understanding EU Regulations and Classifications
(I) Regulatory Basis
Under the EU Medical Device Regulation (EU) 2017/745, electric wheelchairs are classified as medical devices. This regulation covers a wide range of medical products, ensuring their safety and performance meet high standards.
(II) Product Classification
Electric wheelchairs are generally classified as Class I medical devices. This means they are low-risk, but still must meet specific safety and performance requirements.

II. CE Certification
(I) The Importance of CE Certification
CE certification is mandatory for electric wheelchairs to enter the EU market. It demonstrates that the product meets EU safety, health, and environmental requirements.
(II) Applicable Standards
CE certification for electric wheelchairs must comply with the following standards:

EN 12184: Applicable to electric wheelchairs with a maximum speed of up to 15 km/h and a load capacity of up to 300 kg.

EN 60601-1: Essential safety and essential performance requirements for medical electrical equipment. EN 60601-1-2: Tests and requirements for electromagnetic interference.
(III) Certification Process
Test Report: Conduct performance tests (such as ISO 7176), electrical safety tests, electromagnetic compatibility tests, and biological tests.
Technical File: Prepare technical files that comply with MDR requirements, including risk analysis and declaration of conformity.
Registration and Database Entry: Complete applications for SRN (Single Registration Number) and UDI (Unique Device Identifier) and enter them into the EUDAMED database.
EU Registration: Appoint an EU Authorized Representative to be responsible for communication with regulatory agencies and document archiving.

III. Product Testing
(I) Mechanical Performance Testing
Static and dynamic strength tests.
Braking system reliability tests.
Fatigue testing to ensure structural stability after long-term use.
(II) Electrical Safety Testing
Battery overcharge/overdischarge protection.
Circuit protection to prevent short circuits and overloads.
The charger complies with EN 60335. (3) Environmental Adaptability Test
Temperature and Humidity Test (-20°C to 40°C).
Waterproof Performance Test (IP Rating Test).
(4) Labeling and Instructions
Include the CE mark, UDI code, and European Directive information.
Instructions for use must include safety warnings and maintenance instructions.

IV. Quality Management System
(1) ISO 13485 Certification
Electric wheelchair manufacturers must obtain ISO 13485 certification to demonstrate that their quality management systems meet the requirements for medical device production.

V. Clinical Evaluation
(1) Clinical Data
At least 12 months of clinical data on equivalent products must be provided to demonstrate product safety and effectiveness.

VI. Post-Market Surveillance
(1) Vigilance System
Establish a vigilance system to monitor and report adverse events during product use.
(2) Periodic Safety Update Report
Submit a Periodic Safety Update Report (PSUR) annually to ensure that the product continues to meet safety requirements.

VII. Notes
(I) Choosing a Compliance Service Provider
Ensure that the European Representative or certification body is Qualified Person-in-Charge (PRRC) to avoid registration failures.
(II) Long-Term Document Maintenance
Technical documents must be retained for at least 10 years for random inspection by regulatory authorities.
(III) Market Differences
Some countries (such as Switzerland and the UK) require additional registration (UKCA, Swiss registration) in addition to CE certification.

VIII. Summary
Exporting electric wheelchairs to the EU market requires meeting CE certification requirements, completing relevant testing, compiling technical documents, registering, and entering database entries, and designating an EU Authorized Representative. It is recommended to work with a professional certification body to ensure compliance with the regulatory requirements of the target market.
Through systematic certification preparation, companies can typically complete the compliance process within 6-12 months.