Standards and useful links

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

ISO standards

  • ISO14155: Clinical investigation of medical devices for human subjects - Good Clinical Practice (GCP)
  • ISO13485: Medical devices - Quality management systems - Requirements for regulatory purposes
  • ISO14971: Medical devices - Application of risk management to medical devices
  • ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

Useful links

  • MDR guidance for MRECs: Guidance document intended for MRECs, with additional information and examples of medical devices used in clinical investigations under¬†MDR.
  • Guidance - MDCG endorsed documents and other guidance: European Commission guidance to assist stakeholders in implementing the MDR.
  • Evaluation of new technology in health care: Report by the Royal Netherlands Academy of Arts and Sciences (KNAW) that offers the different parties involved concrete handles to choose the method of research that suits the medical device in question best, also in view of the evaluation after market introduction.
  • 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.