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EU IVDR Performance Validation Report Steps and Requirements - MakroCare

Navigate the EU IVDR requirements for in vitro diagnostic medical devices with this comprehensive guide. Ensure compliance and market readiness. https://www.makrocare.com/blog/eu-ivdr-performance-validation-report-steps-and-requirements/

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EU IVDR Performance Validation Report Steps and Requirements - MakroCare

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  1. EU IVDR Performance Validation Report: Steps and Requirements www.makrocare.com

  2. EU IVDR Performance Validation Report: Steps and Requirements European Union in Vitro Diagnostic Regulation (EU IVDR) 2017/746 is the European law concerning placing in vitro diagnostic medical devices for human use and their accessories on the market. Manufacturers of medical devices that wish to place in vitro diagnostic medical devices on the EU market must comply with EU IVDR requirements. The IVDR was introduced in May 2017 to improve the safety and efficacy of in vitro diagnostic medical devices available in the EU market. A comprehensive quality management system (QMS) supports Manufacturers of in vitro diagnostic medical devices to comply with the IVDR requirements regarding quality. It defines an in vitro medical devices as any device used in vitro to examine samples derived from the human body to provide relevant information for material, software, or system used alone or in combination. [ Read more…] www.makrocare.com

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