Obligations for Manufacturers
Definition of a Manufacturer under the EAA
According to the European Accessibility Act, a manufacturer is any natural or legal person who:
- Manufactures a product, or has a product designed or manufactured
- Markets that product under their name or trademark
This definition encompasses companies that:
- Produce physical products covered by the EAA
- Design products but outsource manufacturing
- Rebrand products manufactured by others under their own brand
- Substantially modify products already on the market
Key Responsibilities
As primary economic operators in the supply chain, manufacturers hold the greatest responsibility for ensuring product compliance with the EAA. Their key responsibilities include:
- Ensuring products are designed and manufactured in accordance with the accessibility requirements
- Preparing and maintaining technical documentation
- Carrying out the applicable conformity assessment procedure
- Drawing up an EU Declaration of Conformity
- Affixing the CE marking to compliant products
- Keeping records of non-conforming products and product recalls
- Ensuring serial production maintains compliance
- Providing information on product accessibility in accessible formats
Meeting Accessibility Requirements
Manufacturers must design and produce products that comply with the accessibility requirements set out in Section I of Annex I of the EAA. These requirements include:
- Providing information on the use of the product in accessible formats
- Making user interfaces and functionality accessible to persons with disabilities
- Ensuring compatibility with assistive technologies
- Designing packaging and instructions in an accessible manner
Manufacturers should implement accessibility features from the earliest stages of product design and development, following the principles of "universal design" or "design for all."
Practical Approach:
To meet accessibility requirements, manufacturers should:
- Conduct accessibility assessments during product development
- Involve persons with disabilities in testing
- Follow relevant harmonized standards
- Document all accessibility features and implementation decisions
Conformity Assessment Procedures
Manufacturers must carry out appropriate conformity assessment procedures to verify that their products comply with the accessibility requirements of the EAA. The EAA allows manufacturers to use either:
- Internal production control (Module A) - The manufacturer ensures and declares on their sole responsibility that the products concerned satisfy the applicable requirements.
- EU-type examination (Module B) followed by conformity to type based on internal production control (Module C) - This involves a notified body examining the technical design and the manufacturer ensuring the production process ensures compliance.
For most products, manufacturers can apply Module A (internal production control), which involves:
- Preparing technical documentation
- Taking all necessary measures to ensure manufacturing process and monitoring ensure compliance
- Drawing up a written EU Declaration of Conformity
- Affixing the CE marking to each compliant product
For services, no CE marking is required, but service providers must ensure and declare that their services comply with the accessibility requirements.
Technical Documentation
Manufacturers must prepare and maintain technical documentation that demonstrates how their products meet the accessibility requirements. This documentation must include:
- A general description of the product
- A list of the harmonized standards and/or technical specifications applied
- Description of solutions adopted to meet the accessibility requirements
- Where the manufacturer has used the exception of disproportionate burden, the relevant calculation and assessment
The technical documentation must be kept for at least 5 years after the product has been placed on the market and must be made available to market surveillance authorities upon request.
Note: Technical documentation should be clear, organized, and regularly updated if changes are made to the product. Documentation should be stored in a format that ensures its availability and accessibility throughout the required period.
EU Declaration of Conformity
Manufacturers must draw up an EU Declaration of Conformity when a product has been proven to comply with the applicable accessibility requirements. By drawing up this declaration, the manufacturer assumes responsibility for the compliance of the product.
The EU Declaration of Conformity must:
- State that the fulfillment of accessibility requirements has been demonstrated
- Follow the model structure set out in Annex III of Decision No 768/2008/EC
- Be regularly updated if changes are made to the product
- Be translated into the language(s) required by the Member State where the product is placed on the market
The declaration must be made available to market surveillance authorities for 5 years after the product has been placed on the market.
CE Marking and Product Identification
Manufacturers must affix the CE marking to products that comply with the accessibility requirements of the EAA. The CE marking must be:
- Visibly, legibly, and indelibly affixed to the product
- Affixed before the product is placed on the market
- Followed by the identification number of the notified body (if involved in the conformity assessment)
In addition to the CE marking, manufacturers must ensure that their products bear:
- A type, batch, or serial number allowing product identification
- The manufacturer's name, registered trade name, or registered trademark
- The manufacturer's postal address
Handling Non-Conformity
When manufacturers have reason to believe that a product they have placed on the market does not comply with the accessibility requirements, they must:
- Immediately take corrective measures to bring the product into conformity, withdraw it, or recall it as appropriate
- If the product presents a risk, immediately inform the competent national authorities of the Member States where the product was made available, providing details about the non-conformity and any corrective measures taken
Manufacturers must also have procedures in place to:
- Monitor the compliance of serial production
- Investigate complaints related to accessibility
- Maintain a register of non-compliant products and product recalls
- Keep distributors informed of any such monitoring
Record Keeping Requirements
Manufacturers must maintain comprehensive records to demonstrate compliance with the EAA. They must keep:
- Technical documentation for at least 5 years after the product has been placed on the market
- EU Declaration of Conformity for at least 5 years
- Records of non-conforming products and product recalls
- Information on the economic operators who have supplied them with products and to whom they have supplied products
These records must be made available to market surveillance authorities upon request.
Cooperation with Authorities
Manufacturers must cooperate with competent national authorities when requested. This includes:
- Providing all the information and documentation necessary to demonstrate product conformity
- Cooperating in any action taken to eliminate non-conformity of products they have placed on the market
- Responding to requests from market surveillance authorities in a language that can be easily understood by that authority
Manufacturers should designate a person or department responsible for communication with authorities and maintain clear internal procedures for how to respond to official requests.
Exemptions and Limitations
The EAA recognizes that in some cases, compliance with accessibility requirements might impose a disproportionate burden on manufacturers. The EAA allows for exemptions under the following conditions:
- Disproportionate burden - When implementing the accessibility requirements would require a significant change to the product or service or impose a disproportionate burden on the manufacturer. This must be properly documented and assessed.
- Fundamental alteration - When accessibility requirements would require a fundamental alteration in the nature of the product or service.
- Microenterprises - Microenterprises (fewer than 10 persons and annual turnover/balance sheet not exceeding €2 million) that deal with services are exempt from compliance with the accessibility requirements, but must still notify the relevant Member State authorities.
Important considerations:
When claiming an exemption based on disproportionate burden, manufacturers must:
- Conduct and document an assessment
- Consider the relationship between the costs of compliance and the manufacturer's resources
- Estimate costs and benefits for the manufacturer in relation to the estimated benefit for persons with disabilities
- Re-evaluate the assessment at least every 5 years or when the product changes