IVDR compliance in clinical trials

QC statement and guidelines on using the statement

QC statement – Compliance with IVDR (EU 2017/746) in Danish Clinical Trials conducted
according to CTR (EU 536/2014). 

Guidelines on using the statement: QC Statement – Compliance with IVDR (EU 2017/746) in Danish Clinical Trials conducted according to CTR (EU 536/2014).