Konformitätsverfahren

The Konformitätsverfahren, commonly referred to as the conformity assessment procedure, is a systematic approach used in various regulatory frameworks to ensure that products, services, or systems meet specified requirements, standards, or regulations. This process is widely applied in fields such as product safety, environmental protection, and technical standardization to verify compliance before market introduction or use.

In the European Union, the Konformitätsverfahren is a key component of the New Approach and Global Approach directives, which aim to harmonize technical regulations across member states. The procedure typically involves assessing whether a product complies with essential requirements outlined in legislation, such as the Machinery Directive (2006/42/EC) or the Low Voltage Directive (2014/35/EU). Manufacturers or their authorized representatives are responsible for demonstrating conformity through internal checks or external evaluations, depending on the product category and risk level.

The process generally includes steps such as risk assessment, documentation review, testing, and certification. For high-risk products, third-party conformity assessment bodies, such as notified bodies, may conduct inspections or audits to validate compliance. Once conformity is established, the manufacturer affixes a CE marking to indicate that the product complies with applicable EU requirements and is free to be placed on the market.

Beyond the EU, similar conformity assessment procedures exist in other jurisdictions, such as the United States’ Federal Food, Drug, and Cosmetic Act or the International Organization for Standardization’s (ISO) voluntary standards. These procedures help ensure product safety, interoperability, and consumer protection while facilitating international trade by reducing technical barriers.

The Konformitätsverfahren emphasizes a risk-based approach, prioritizing safety and performance while minimizing unnecessary bureaucratic burdens. It encourages manufacturers to take responsibility for compliance while allowing regulatory authorities to focus on oversight and enforcement.