The COVID-19 pandemic has highlighted the need for European health policy decisions to be guided by scientific and clinical experts.

Aim of the Part I of the workshop is to inform policymakers about the new In Vitro Diagnostics Regulation (IVDR) and its consequences for the EU health system. The application date for the new IVDR is set for May 2022. This regulation contains new provisions to enhance the safety of diagnostics in the EU, and will affect health professionals, academics, labs, industry, and patients.Part II of the workshop will debate the importance of evidence-based health policies, looking at three case studies; the EU cooperation on health technology assessment (HTA); the use of clinical real-world data to guide healthcare policies; and the need for better evaluation and regulation of artificial intelligence in medicine.