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On April 15, 2024, the Medical Device Coordination Group (MDCG) released a new guidance document; MDCG 2024-4 Safety Reporting in Clinical Performance Studies of in Vitro Diagnostic (IVD) under the EU IVD Regulation (2017/746, IVDR). The guidance provides an in-depth look at safety reporting requirements for IVD performance studies under the IVDR. It introduces a tabular performance study Summar..

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) requires that the manufacturer shall draw up a summary of safety and performance (SSP) for class C and D devices, other than devices for performance studies. The SSP shall be validated by a notified body (NB) and made available to the public via the European database on medical devices (Eudamed). Text elements in italic i..

Earlier this month I wrote about the importance of clinical trial transparency and the FDA’s oversight. Today, I’d like to catch up with you about another critical component of FDA’s oversight of clinical studies: our work to harmonize clinical research regulations and to facilitate the development of medical products to benefit public health. Modernizing Clinical Research Oversight Efficient, w..