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