Clinical investigations under the MDR: New Revision of MDCG on Safety reporting

The Medical Devices Coordination Group (MDCG) released on October 2022 a new revision to their MDCG guidance on safety reporting in clinical investigations of medical devices under Regulation (EU) 2017/745. This guidance addresses the circumstances under which safety reporting should be carried out and what the report should include. As this guidance is already covered in Oh! It looks like you do not have access to this page.
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