Performance study application guidance for in vitro diagnostics until EUDAMED available published

Article summary

The Medical Device Coordination Group (MDCG) has published the performance study application/notification documents under Regulation (EU) 2017/746 (the In Vitro Diagnostic Medical Devices Regulation (IVDR)), which provides the application and notification documents that sponsors submit to the Member State where the study is to be conducted in accordance with Chapter I of Annex XIV of the IVDR. Article 69 of the IVDR requires these to be submitted electronically, but until EUDAMED is fully functional this guidance provides the documents for the application and notification to Member States. These are as similar as possible to EUDAMED.