Focus on Manufacturing: Unlike Module B, which focuses on design examination, Module D focuses strictly on the production process and final product control. It ensures that the manufacturer has a quality system in place to consistently produce goods that match the approved design.

Quality System Assessment: Under this module, a Notified Body (NB) audits the manufacturer's production quality system (often based on ISO 9001 standards) to verify that it meets EU regulatory requirements.

Continuous Surveillance: Module D is not a one-time test. It requires ongoing surveillance, including regular annual factory audits and unannounced inspections by the Notified Body to ensure the quality system remains effective.

Common Combinations: Module D is rarely used alone. It is typically combined with Module B (EC Type Examination). The Module B + Module D combination is very common for high-risk products, meaning the product design is approved (Module B), and the mass production is continuously monitored (Module D).

Our factory have a robust, EU-audited quality management system in place to guarantee consistent manufacturing quality.
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