European Government Procurement Process and Requirements for Electric Wheelchairs

European Government Procurement Process and Requirements for Electric Wheelchairs

I. Core Process for European Government Procurement of Electric Wheelchairs: From Announcement to Contract Performance
European government procurement follows the Public Procurement Directive (2014/24/EU). As medical devices, electric wheelchairs have a standardized and rigorous procurement process, consisting of six key stages:

1. Public Request for Procurement

The purchaser (EU institution, member state government, or local health department) must publish a tender notice on TED (Official Tendering Daily of the European Union), specifying the core project information:

Purchase Target: Type of electric wheelchair (standard, smart, outdoor off-road, etc.), quantity, and delivery time;

Technical Benchmark: Required EU harmonized standards (such as EN 12184) and performance indicators (such as gradeability and range);

Qualification Requirements: Bidders must possess ISO 13485 quality management system certification and be an EU Authorized Representative (EU Representative).

Note: Small and medium-sized procurement projects (below the threshold) may only be announced on local member state platforms, such as SIMAP in Germany and BOAMP in France.

2. Bidding Document Preparation and Submission

Bidders must submit a complete set of documents within the specified deadline, including the following:

Company Qualifications: Business License, Authorization Letter from the European Commission (EUDAMED) and Registration Certificate;

Product Compliance Documents: CE Mark Certificate, UDI Code Certificate, and Summary of Technical Documents (Document of Conduct);

Commercial Response Materials: Quotation, Lead Time Commitment, and After-Sales Service Plan (must include local repair network information).

Key Note: The EU IPI measures, effective June 2025, prohibit Chinese companies from participating in projects with a contract value exceeding €5 million. For projects below this value, the proportion of Chinese-made products must not exceed 50%.​

3. Prequalification and Review
The purchaser will form a professional review panel to conduct an assessment based on compliance, technical compatibility, and economic feasibility:

Compliance Review: Focuses on verifying the qualifications of the notified body for CE certification (e.g., TÜV, SGS) and the product’s certificate of origin;

Technical Review: Evaluates core indicators such as braking performance and electromagnetic compatibility based on the EN 12184 standard test report;

Price Evaluation: Lowest bidders, provided they meet technical requirements, will be given an advantage, but compliance concerns arising from abnormally low bids must be avoided.

4. Bid Winning Announcement and Contract Signing

The winning bid must be announced on the TED for at least 10 business days. If no objections are raised during the announcement period, the purchase contract will be signed. The contract must clearly state:

Product acceptance criteria: including sampling testing clauses (e.g., randomly selecting 3% of products for dynamic stability re-inspection);

Warranty terms: typically requiring a warranty of at least two years, with core components (batteries, motors) requiring separate warranty extensions;

Compliance commitment: The supplier must ensure that the product continues to comply with MDR regulations and UDI traceability requirements.

5. Production and Delivery Phase

The supplier must strictly organize production in accordance with the contract requirements and, prior to delivery, complete:

UDI code assignment for each product (must be linked to the EUDAMED database);

Multilingual instruction manuals (at least in the official language of the purchasing country) and CE marking;

Factory inspection report (including electrical safety test data). 6. Acceptance and After-Sales Performance
The purchaser will conduct an on-site acceptance inspection in accordance with the EN 12184 standard, focusing on the following tests:

Braking system: 10° slope standstill test and braking effectiveness in the de-energized state;

Electrical safety: Insulation resistance (≥2MΩ) and leakage current (≤0.5mA);

Accessibility: Verification of controller tactile differentiation and warning sound intensity (55-65dB).

After passing the acceptance inspection, the supplier will fulfill its after-sales obligations, including regular maintenance and fault response (usually requiring on-site response within 48 hours).​
II. Core Requirements for European Government Procurement: Technology, Compliance, and Localization

1. Technical Standards: Comprehensive Specifications Core to EN 12184

As Class IIa medical devices (some complex intelligent models are Class IIb), electric wheelchairs must meet multiple EU harmonized standards, with EN 12184 being the most important standard for purchasers:

Testing Dimensions

Key Requirements

Example of Failure

Mechanical Safety

Seat must withstand a static load of 125kg for 5 minutes without deformation

A certain brand was rejected due to failure of the frame fatigue test

Electrical Safety

Motor temperature rise ≤ 75K, battery overcharge protection effective

PCB protection does not meet IP54 standards and requires rectification

Electromagnetic Compatibility

Operating normally under 3V/m RF field strength

Variable frequency drive models with excessive radiation emissions require the addition of a magnetic ring

Accessibility

Controller must be operated with one hand, with a button diameter difference of ≥ 2mm

Inadequate tactile differentiation leads to 23% Failure Rate

In addition, buyers often require compliance with ISO 10993 biocompatibility standards (for skin-contact parts) and UN38.3 battery transport standards.

2. Compliance Requirements: Full Lifecycle Management under the MDR

Certification and Registration: Requires obtaining a CE certificate through a Notified Body, completing an SRN application and EUDAMED registration, and designating a European Representative to liaise with regulatory authorities.

Risk Management: Requires submitting a risk assessment report based on ISO 14971, covering risk control measures throughout the design, production, and use phases.

Traceability Requirements: Each product must be traceable through the entire UDI process, including data linkage from production, distribution, and use.
3. Localization Requirements: The Key to Breaking Market Barriers

Supply Chain Localization: To address IPI restrictions, core components can be substantially processed in the EU or a third country, and a certificate of origin can be issued to meet the 50% ratio requirement.

Service Localization: Repair locations must be established in the purchasing country or partnerships must be established with local service providers to provide spare parts inventory and technical support.

Document Localization: All technical documents must be translated into the language of the purchasing country, and manuals must include local after-sales contact information and a compliance statement.

III. Response Strategies for Chinese Companies: Compliance Breakthroughs and Case Studies

1. Compliance Response: Overcoming IPI Restrictions and Certification Challenges

Supply Chain Optimization: Collaborate with contract manufacturers in Central and Eastern European countries such as Hungary and Poland to obtain certificates of origin through “EU processing” to circumvent the 50% ratio requirement.

Speeded Certification: Prepare technical documents (design drawings, risk reports, etc.) in advance and choose an expedited certification process with a Notified Body to shorten the certification process to 3-5 weeks (assuming all documents are complete).

Intellectual Property Protection: Apply for design and technology patents in the EU to mitigate infringement risks.​
2. Success Case: Domestic Enterprises’ Global Expansion Practices

A domestic smart wheelchair brand, A, successfully entered the Nordic government procurement market through a three-pronged strategy:

Product Customization: Targeting the snowy terrain of Nordic countries, the brand enhanced its climbing performance (exceeding the EN 12184 standard by 30%) and passed EMC testing optimization;

Compliance Strategy: Established an EU representative office in Germany and completed EUDAMED registration and UDI code application;

Channel Partnership: Partnered with local Swedish medical device distributors, sharing their after-sales network. The brand gradually expanded into the market through small and medium-sized projects (less than €5 million), achieving a 120% sales increase within two years.

3. Risk Mitigation: Common Pitfalls and Solutions

Certification Pitfalls: Avoid trusting “test-free certification” and choose an EU-recognized Notified Body (check the EUDAMED list of notified bodies);

IPI Risks: Obtain a customs pre-determination to confirm the product’s origin before bidding to avoid being identified as a “circumvention measure”;

Post-sales Risks: Purchase product liability insurance to cover potential safety incident compensation.

IV. Conclusion: Seizing Policy Opportunities to Build Long-Term Competitiveness

Although the European government procurement market faces new challenges such as IPI measures, the growing demand driven by an aging population still presents opportunities for Chinese companies. We recommend that companies prioritize compliance as the foundation, technology as the core, and localization as the nexus. Focus on:

Tracking the 2023 revision of the EN 12184 standard (with new cybersecurity requirements);

Developing local EU supply chains to address IPI restrictions;

Participating in international exhibitions such as Medica to connect with buyers and local distributors.