PARIS – It's almost official. After eight years of hard-fought negotiating, the European Parliament repealed the 30-page Medical Device Directives governing the Conformité Européen certification, or CE Mark, and adopted the 600 pages of the Medical Device Regulation (MDR) and In vitro Diagnostic Medical Devices (IVDR).

PARIS – The CE mark is dead, long live the new CE mark. Five years after launching a reform of regulations for commercializing medical devices and in vitro diagnostics (IVDs), the European Council released the final text for the Medical Device Regulations (MDR) and IVD Regulations (IVDR), setting in motion a countdown to enforcement. "The future is in this version and like it or not, this is what we will work with, what we need to make a success, because the alternative that it does not work is so much worse," said Ronald Boumans, the...

PARIS – The CE mark is dead, long live the new CE mark. Five years after launching a reform of regulations for commercializing medical devices and in vitro diagnostics (IVDs), the European Council released the final text for the Medical Device Regulations (MDR) and IVD Regulations (IVDR), setting in motion a countdown to enforcement.