Annex V: Conformity Assessment for Products

Annex V of the European Accessibility Act (EAA) establishes the procedures for assessing whether products comply with the applicable accessibility requirements. This annex outlines two conformity assessment modules that manufacturers can use: internal production control (Module A) and EU-type examination followed by conformity to type (Modules B and C).

The conformity assessment process is a critical step that manufacturers must complete before placing products on the EU market. It ensures that products meet the accessibility requirements specified in Annex I of the EAA and serves as the basis for the EU Declaration of Conformity and CE marking.

Internal production control (Module A) is the simplest conformity assessment procedure, where the manufacturer takes full responsibility for ensuring and declaring that the products concerned satisfy the applicable requirements.

Key Elements of Internal Production Control

This module consists of the following elements that manufacturers must implement:

1. Technical Documentation: The manufacturer must establish technical documentation that enables assessment of the product's conformity with the relevant accessibility requirements. The documentation must specify:
   • A general description of the product
   • A list of the harmonized standards and technical specifications applied
   • Descriptions and explanations necessary for understanding the product's operation and its accessibility features
   • Design and manufacturing drawings and schemes of components, sub-assemblies, and circuits
   • Results of design calculations and examinations carried out
   • Test reports related to accessibility features
2. Manufacturing Process Controls: The manufacturer must take all measures necessary to ensure that the manufacturing process and its monitoring ensure compliance of the manufactured products with:
   • The technical documentation prepared in the previous step
   • The applicable accessibility requirements in Annex I
3. Conformity Marking and Declaration: The manufacturer must:
   • Affix the CE marking to each individual product that satisfies the applicable requirements
   • Draw up a written EU Declaration of Conformity for each product model
   • Keep the technical documentation and EU Declaration of Conformity for five years after the product has been placed on the market
4. Authorized Representative: The manufacturer's obligations may be fulfilled by an authorized representative, on behalf and under the responsibility of the manufacturer, provided they are specified in the mandate.

When to Use Internal Production Control

Internal production control is most appropriate when:

• The product design is relatively straightforward with respect to accessibility features
• The manufacturer has strong in-house expertise in accessibility and conformity assessment
• The accessibility requirements applicable to the product are well understood and can be reliably verified through internal testing
• Harmonized standards exist that cover all the applicable accessibility requirements for the product

EU-type examination (Module B) is the part of a conformity assessment procedure in which a notified body examines the technical design of a product and verifies and attests that it meets the applicable accessibility requirements.

Process for EU-Type Examination

This module involves the following steps:

1. Application to Notified Body: The manufacturer must lodge an application for EU-type examination with a single notified body of their choice. The application must include:
   • Name and address of the manufacturer
   • A written declaration that the same application has not been lodged with any other notified body
   • The technical documentation as described in Module A
   • Representative samples of the production envisaged
   • Supporting evidence for the adequacy of the technical design solution, including any standards applied
2. Assessment by Notified Body: The notified body will:
   • Examine the technical documentation to assess the adequacy of the technical design of the product in relation to the applicable accessibility requirements
   • Verify that the samples have been manufactured in conformity with the technical documentation
   • Carry out appropriate examinations and tests, or have them carried out, to check whether the product complies with the applicable accessibility requirements
   • Agree with the manufacturer on the location where the examinations and tests will be carried out
3. Evaluation Report and Certificate: The notified body will:
   • Draw up an evaluation report recording the activities undertaken and their outcomes
   • Issue an EU-type examination certificate if the product type complies with the applicable accessibility requirements
   • Refuse to issue a certificate if the product does not meet the accessibility requirements, informing the applicant and providing detailed reasons
4. Ongoing Obligations: After certificate issuance:
   • The notified body must stay informed of changes in the generally acknowledged state of the art that might affect compliance
   • The manufacturer must inform the notified body of any modifications to the approved type that may affect conformity
   • The notified body must review changes and determine if further examination is required

This module follows Module B and focuses on ensuring that manufactured products conform to the approved EU-type examination certificate. It is the manufacturer's responsibility to ensure this conformity through internal production controls.

Key Requirements for Conformity to Type

Under Module C, the manufacturer must:

1. Manufacturing Controls: Take all measures necessary to ensure that the manufacturing process and its monitoring ensure that the manufactured products conform to the approved type described in the EU-type examination certificate and comply with the applicable accessibility requirements.
2. CE Marking and Declaration:
   • Affix the CE marking to each individual product that conforms to the approved type and satisfies the applicable requirements
   • Draw up a written EU Declaration of Conformity for each product model
   • Maintain a copy of the EU Declaration of Conformity available for national authorities for five years after the product has been placed on the market
3. Authorized Representative: The manufacturer's obligations may be fulfilled by an authorized representative, provided they are specified in the mandate.

Manufacturers have flexibility in choosing which conformity assessment procedure to follow based on specific circumstances:

Factors to Consider

• Product Complexity: More complex products with numerous accessibility features may benefit from the greater scrutiny provided by EU-type examination.
• Market Risk: Products where accessibility failures could significantly impact users or lead to higher liability might warrant external verification through Modules B and C.
• Manufacturer Experience: Companies with limited experience in accessibility implementation might gain confidence and reduce risk by using external notified bodies.
• Available Standards: Where harmonized standards fully cover the product, internal production control may be sufficient; where gaps exist, external verification provides additional assurance.
• Business Considerations: While Module A (internal production control) is typically faster and less costly, Modules B and C may provide market advantages through third-party verification.

Decision Guide

In general, manufacturers should consider using:

• Module A (Internal Production Control) when:
  • The product has straightforward accessibility features
  • The organization has strong internal accessibility expertise
  • Harmonized standards completely cover all applicable requirements
  • The product represents low risk in terms of accessibility impact
• Modules B and C (EU-Type Examination and Conformity to Type) when:
  • The product has complex accessibility features
  • The organization has limited accessibility expertise
  • Few harmonized standards exist for the product type
  • Third-party verification would strengthen market position
  • The product would significantly impact users if accessibility features fail

Regardless of which module is chosen, robust technical documentation is essential for conformity assessment. The technical documentation must include:

Comprehensive Documentation Components

1. General Product Description:
   • Overview of the product's purpose, functionality, and target users
   • Identification of components, parts, and subassemblies
   • Description of user interfaces and interaction methods
2. Accessibility Features Documentation:
   • Detailed description of how each applicable accessibility requirement is met
   • Screenshots, diagrams, and examples of accessibility implementations
   • Explanations of design choices made to support accessibility
   • User documentation related to accessibility features
3. Standards and Specifications:
   • List of harmonized standards applied in full or in part
   • Descriptions of solutions adopted to meet requirements where harmonized standards haven't been applied
   • References to technical specifications used
4. Design and Manufacturing Information:
   • Drawings, diagrams, and specifications of components related to accessibility
   • Manufacturing processes that ensure consistent implementation of accessibility features
   • Quality control procedures for accessibility features
5. Test Results and Assessments:
   • Results of accessibility tests performed
   • Test methodologies and validation procedures
   • User testing with persons with disabilities (if conducted)
   • Analysis of test results and corrective actions taken
6. Risk Assessment:
   • Identification of accessibility-related risks and potential failure points
   • Mitigations implemented to address identified risks
   • Analysis of residual risks and justifications for accepting them

Notified bodies play a crucial role in the conformity assessment procedures, particularly for Module B (EU-type examination).

Key Responsibilities of Notified Bodies

• Technical Assessment: Evaluating whether a product's technical design meets the accessibility requirements specified in the EAA
• Testing and Verification: Conducting or supervising tests to verify compliance with accessibility requirements
• Certificate Issuance: Issuing EU-type examination certificates for compliant products
• Ongoing Monitoring: Staying informed about changes in standards and state of the art that might affect compliance
• Change Assessment: Evaluating manufacturer-notified changes to determine if they affect compliance
• Documentation: Maintaining records of assessments and decisions

Selecting a Notified Body

When choosing a notified body for conformity assessment, manufacturers should consider:

• Scope of Designation: Ensure the body is authorized to assess the specific product category
• Accessibility Expertise: Evaluate the body's specific expertise in accessibility assessment
• Assessment Approach: Understand their methodology and requirements
• Reputation and Experience: Consider their track record with similar products
• Timing and Cost: Compare their process timeframes and fee structures
• Support Services: Determine what guidance they provide during the assessment process

Each EU Member State publishes a list of notified bodies designated for conformity assessment under the EAA, along with their identification numbers and the specific tasks for which they have been designated.

The conclusion of the conformity assessment procedure leads to two important elements: the EU Declaration of Conformity and CE marking.

EU Declaration of Conformity

The EU Declaration of Conformity is a document in which the manufacturer states that the product meets all applicable accessibility requirements. It must contain:

• Product identification (model, type, batch, or serial number)
• Name and address of the manufacturer or authorized representative
• A statement that the declaration is issued under the sole responsibility of the manufacturer
• Identification of the product allowing traceability
• Reference to the EAA and other relevant EU legislation
• References to relevant harmonized standards or specifications used
• Where applicable, the name and number of the notified body and reference to the EU-type examination certificate
• Signature, date, and place of issue

CE Marking

The CE marking:

• Must be affixed visibly, legibly, and indelibly to the product
• Must appear on the product packaging if it cannot be placed on the product itself
• Must be applied before the product is placed on the market
• May be followed by the identification number of the notified body if one was involved in the production control phase
• Signifies that the product conforms with all applicable EU legislation, including the EAA

By applying the CE marking, the manufacturer takes full responsibility for the product's conformity with all applicable requirements of relevant EU legislation.

Manufacturers must maintain certain documentation related to conformity assessment for a specified period:

• Technical Documentation: Must be kept for five years after the product has been placed on the market
• EU Declaration of Conformity: Must be retained for five years after the last product has been made available
• EU-Type Examination Certificate and Annexes: Must be kept as part of the technical documentation
• Changes to Approved Type: Documentation of modifications and additional approvals must be maintained
• Correspondence with Notified Bodies: Should be retained as part of the conformity documentation

These records must be made available to market surveillance authorities upon request and serve as evidence of the product's compliance with accessibility requirements.

Annex V works in conjunction with other parts of the EAA:

• Annex I (Accessibility Requirements): Defines the accessibility requirements that must be assessed during conformity procedures
• Annex II (Examples of Implementation): Provides non-binding examples that can guide implementation and assessment
• Annex IV (Disproportionate Burden Assessment): May be relevant if a manufacturer claims certain requirements would impose a disproportionate burden
• Annex VI (Assessment Criteria): Provides more detailed criteria for assessing disproportionate burden claims that might affect the scope of conformity assessment

Understanding these relationships is important for manufacturers to correctly apply the conformity assessment procedures in the context of the EAA as a whole.