Compliance and regulatory agility in production

An iterative approach to CE conformity without standardized standards

Abstract

This article presents an iterative CE approach. This approach enables companies to meet their safety and security requirements and achieve CE conformity even without harmonized standards, despite increasing system complexity and new regulatory requirements. Repeated risk assessments, accompanying validations, blueprints, digital twins and a practical example are used to show how technical development and normative requirements can be consistently combined.