Regulation (EU) 2017/745 (EU MDR) is in force from May 26, 2021.
It had become immediately enforceable as law in all member states simultaneously. The regulatory framework for medical device manufacturers having their devices admitted to the EU market significantly changed.
Range of devices undergoing an external review of regulatory dossier expanded. Clinical data are a crucial element for acquiring and maintaining device certification under MDR. Requirements for the quality and validity of clinical data are uniform and harmonized.
KCRI operates entirely within the MDR realm. Device manufacturers receive full support and guidance from KCRI to set up and manage their clinical development programs – both pre- and post-marketing phases.