How to Apply for EU MDR and Machinery Directive Certification for Electric Wheelchairs

How to Apply for EU MDR and Machinery Directive Certification for Electric Wheelchairs

I. Overview
The EU Medical Device Regulation (MDR 2017/745) officially came into effect on May 26, 2021, replacing the previous Medical Device Directive (MDD 93/42/EEC). As a medical device, electric wheelchairs must meet the requirements of the MDR before they can be sold on the EU market. In addition, electric wheelchairs must comply with the relevant requirements of the Machinery Directive (2006/42/EC).

II. MDR Certification Process
(I) Product Classification
Under the MDR, electric wheelchairs are generally classified as Class I medical devices. If an electric wheelchair has more complex features, such as electronic control systems or life support functions, it may be classified as Class IIa or Class IIb.
(II) Technical Documentation Preparation
Device Description and Specifications: This includes the model, accessories, intended use, and operating principle.
Manufacturer Information: The labeling and instructions for use must be consistent with the device description.
Design and Manufacturing Information: A detailed description of the production process and quality control.
General Safety and Performance Requirements: Compliance must be demonstrated through a checklist or table. Risk Analysis and Risk Management: Includes risk assessment and control measures. Product Verification and Validation: Covers tests such as biocompatibility, safety, and stability. (III) Clinical Evaluation: Electric wheelchairs require clinical evaluation to demonstrate their safety and effectiveness. The Clinical Evaluation Report (CER) should include the following: Device Description and Technical Documentation: Clarifies the product classification, intended use, technical characteristics, and analysis of differences with similar products. Clinical Data Sources: Includes proprietary clinical trial data, literature reviews of equivalent devices, and post-marketing surveillance (PMS) data. Clinical Evaluation Plan (CEP): Develops a detailed data retrieval strategy, screening criteria, and analysis methods. Data Analysis and Conclusions: Assess the quality of evidence using the GRADE system, present the benefit-risk ratio through a risk matrix, and the conclusions must clearly support the Declaration of Conformity. (IV) Declaration of Conformity: The manufacturer must sign and issue a Declaration of Conformity (DoC) stating that the electric wheelchair complies with all applicable EU regulations and standards. (V) Review by a Notified Body: Select a Notified Body to review and approve the product’s technical documentation, risk management, and clinical evaluation. (VI) CE Marking
After passing all necessary reviews, manufacturers can affix the CE mark to their products, indicating compliance with the MDR.

III. Machinery Directive Certification Process
(I) Machinery Directive Requirements
Electric wheelchairs must comply with the requirements of the Machinery Directive (2006/42/EC) to ensure their safety during use. Specific requirements include:
Mechanical strength and stability: Ensure that the electric wheelchair is structurally sound under all conditions of use to prevent tipping or structural failure.
Operational safety: Includes speed control, emergency stop functions, and other features to ensure the safe operation of the electric wheelchair under all circumstances.
Electrical safety: Ensure the safety of the electrical system, including the charging system and protective devices against overload and short circuits.
Risk assessment: Manufacturers must conduct a risk assessment to identify and evaluate potential risks in the design, manufacture, and use of the electric wheelchair and implement appropriate protective measures.
Instruction manual: Provide detailed instructions, including detailed steps for installation, operation, maintenance, and troubleshooting, and clearly identify potential hazards and preventative measures.
(II) Testing and Verification
Electrical wheelchairs are subject to the following testing and verification:
Electrical safety testing: Electrical safety testing is performed in accordance with the EN 12184 standard.
Mechanical stability and structural strength testing: Ensures that the wheelchair will not cause accidents due to mechanical problems during use.
Braking system and control system testing: Ensures that the wheelchair’s braking and control systems function properly under various conditions.
Electromagnetic compatibility (EMC) testing: Electromagnetic compatibility testing is performed in accordance with Directive 2014/30/EU.
Low Voltage Directive (LVD) testing: Low voltage testing is performed in accordance with Directive 2014/35/EU.

IV. EU Registration and Authorized Representative
(I) EU Registration
Before placing an electric wheelchair on the EU market, manufacturers must obtain EU registration. The registration process includes:
SRN (Single Registration Number) application: Manufacturers must apply for an SRN, which serves as their identification in the EUDAMED database.
EU database submission: Manufacturers must submit product information, including the Basic UDI-DI and UDI-DI, to the EUDAMED database. (2) EU Authorized Representative
Manufacturers must designate an EU Authorized Representative (EU Rep), whose primary responsibilities include:
Document Retention: Preserving the Declaration of Conformity, labeling, packaging, instructions for use, notified body certification, post-market surveillance data, and incident reports.
Safety Vigilance: Assisting manufacturers with product incident reporting and recalls.
Information Provision: Providing necessary technical documentation and information to EU competent authorities.
Compliance Verification: Verifying the manufacturer’s Declaration of Conformity, conformity assessment procedures, and registration status.

V. Post-Market Surveillance
(1) Post-Market Clinical Follow-up (PMCF)
Manufacturers must establish and implement a Post-Market Clinical Follow-up (PMCF) system to proactively collect and evaluate performance and relevant scientific data during the use of medical devices to ensure the safety and effectiveness of the devices.
(2) Vigilance
Manufacturers must establish a vigilance system to notify and evaluate incidents and Field Safety Corrective Actions (FSCAs).
(3) Periodic Safety Update Report (PSUR)
Manufacturers must submit a Periodic Safety Update Report (PSUR) annually to ensure ongoing product compliance.

VI. Product Packaging and Labeling
(I) Labels and Instructions
The labels and instructions for electric wheelchairs must comply with ISO 7176-15 and other ISO 7176 standards, be accurate and complete, and comply with FDA regulations.
(II) Packaging Materials
Packaging materials must provide good protective properties to ensure the product is not damaged during transportation and storage.
(III) Package Labeling
Packaging labels must contain key information consistent with the label and comply with FDA package labeling specifications.
(IV) UDI System
Manufacturers must assign a unique device identifier (UDI) and enter the relevant information into the GUDID and EUDAMED databases.

VII. Summary
The process for applying for EU MDR certification and compliance with the Machinery Directive for electric wheelchairs is complex and involves multiple steps and requirements. Manufacturers must ensure that their products comply with all applicable regulations and standards and establish a comprehensive quality management system and post-market surveillance system. Through systematic certification preparation, manufacturers can typically complete the compliance process within 6-12 months. It is recommended to work with a consulting firm with experience in medical devices to reduce certification risks and time costs.