Overview

While evidence requirements have changed under the new European framework for CE arking, the movement towards pan-European Health Technology Assessment also has gained traction, prompting greater conformity of HTA evidence requirements and "transplantation" of evidence reviews across geographies within the European Union.  Companies can expect CE Mark requirements to be more aligned with the demands of HTA bodies for reimbursement, but the challenges for medical device firms are greater, as local HTA bodies may be commissioned to implement assessments that have a pan-European impact.