This document applies to individuals performing regulatory reviews and making decisions associated with the regulatory review for IVD and non IVD medical devices, on behalf of Regulatory Authorities and/or their recognized CABs. This document recognizes the use of Regulatory Reviewers and Technical Experts in the regulatory review process and provides separate training and competency requirements for each.

This document does not establish competency and training requirements for MDSAP Auditors and MDSAP Regulatory Authority Assessors. These requirements are already addressed in the MDSAP working group documents (IMDRF/MDSAP WG/N4 FINAL:2013 and IMDRF/MDSAP WG/N6 FINAL:2013).

 

Competence, Training, and Conduct Requirements for Regulatory Reviewers