Standards and useful links

Below is listed an overview of relevant ISO standards and useful links.

ISO standards

  • ISO20916: In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice.
  • ISO15189: Medical laboratories — Requirements for quality and competence.

Useful links

  • IVDR guidance for MRECs: Guidance document intended for MRECs, with additional information and examples of performance studies using in-vitro diagnostics under IVDR.
  • Guidance - MDCG endorsed documents and other guidance: European Commission guidance to assist stakeholders in implementing the MDR and the IVDR.
  • ToetsingOnline: Internet portal for the submission, assessment, registration and publication of medical research involving human subjects.
  • Committee Finder: Online tool to determine which committee should assess your investigation.