Standards and useful links | The Central Committee on Research Involving Human Subjects

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.
Research Portal: portal for registering, submitting and managing medical research.