EU MDR/IVDR Readiness Assessment

Take the Assessment

The new EU MDR/IVDR introduces sweeping reforms that require manufacturers to provide all content necessary to demonstrate that your device meets compliance requirements in an official European Union language as determined by the Member State. For manufacturers, this means an added responsibility to provide accurate, meaningful product content that can be translated, versioned and controlled centrally with consistency. 

Manufacturers should ask themselves: 

  • How will we expand our translation resources to support post-market surveillance and the performance assessments required by the new regulations? 
  • How will I manage the manufacture, analysis, management, authorization, marketing and distribution of content for medical devices in the language(s) designated by the Member State? 
  • How can I manage the content supply chain to be compliant and to remain compliant? The questions in this assessment will assist your organization by identifying technologies and steps you can take to simplify your EU MDR/IVDR content management and translation processes.