The International Medical Device Regulators Forum (IMDRF) recently published guidance intended to streamline regulatory reporting requirements across jurisdictions. The document lays out expectations not just for medical device sponsors but also for reviewers to improve consistency and reduce burdens for companies bringing products to different markets.
In early February, IMDRF published a final guidance entitled, Medical Device Regulatory Review Report: Guidance Regarding Information to be Included. The document applies solely to medical device, and not to in vitro diagnostics, and is part of a set of guidances the group has produced to harmonize the medical device review process across regulatory jurisdictions.
IMDRF said its guidances Competence, Training, and Conduct Requirements for Regulatory Reviewers and Requirements for Medical Device Conformity Assessment Bodies for Regulatory Authority Recognition are meant to be complimentary guidances, and it lists several other documents that may be applicable…
