MDCG 2022-10: Interfaces between the Clinical Trial Regulation and IVDR
Assays used in clinical trials may range from CE-marked IVDs to trial- or medicinal product-specific assays that are not always meant to be developed as IVDs. In order to assure that conformity is maintained on both the drug and device sides, MDCG—with the Clinical Trials Expert Group (CTG)—have published a Q&A document to clarify requirements for these assays.