konformitetsrapport

Konformitetsrapport is a Swedish term used for a formal document that documents how a product complies with applicable regulatory requirements, primarily within the European Union’s conformity assessment framework. It is part of the process that supports CE marking and demonstrates that the product meets essential safety, health, and environmental protection requirements set out by relevant directives and regulations.

The report typically summarizes the conformity assessment approach taken for the product. Contents commonly include product identification, the directives and harmonized standards applied, results of testing and validation, risk assessment and mitigation measures, information about the manufacturing process and quality management system, and references to the technical documentation and test reports. It often outlines the route of conformity assessment, including whether a Notified Body was involved and, if so, which certificates or opinions were issued. The konformitetsrapport also supports the supplier’s EU Declaration of Conformity, which declares that the product complies with all applicable requirements.

Who prepares it can vary. In many cases the manufacturer compiles the konformitetsrapport as part of the technical documentation; for products requiring third‑party assessment, a Notified Body may contribute or provide the official conformity certificate that the report summarizes.

In practice, the term is used in Sweden in the context of EU harmonization and market surveillance. It is a documentation tool rather than a stand‑alone certificate, serving to evidence conformity alongside theDeclaration of Conformity and the accompanying technical documentation.