The Regulation (EU) 2017/246 (IVDR) is complex, and the interpretation can be challenging. Ensuring compliance with the IVDR in the European Union necessitates the production of comprehensive supporting documentation. At QRcompliance, we are dedicated to assisting professionals in interpreting the IVDR provisions and compiling the requisite documentation.

Our goal is to simplify compliance, helping you navigate the complexities of the IVDR with ease and ensuring your products meet all requirements. Therefore, QRcompliance has developed intuitive templates on various facets of the IVDR, for creating compliant documents.

Let QRcompliance be your partner in IVD regulatory compliance.

Template - Intended Purpose Statement

Template - IVD Classification

Template - General Safety and Performance Requirements (GSPR)

Template - Summary Technical Documentation (Annex II)

Template - EU Declaration of Conformity