Guidance on Breakthrough Devices under Regulations 2017/745 & 2017/746

In certain circumstances, a medical device or in vitro diagnostic medical device may be described as a breakthrough device when it represents an innovation that is expected, based on available information, to offer a novel diagnostic or therapeutic option addressing an unmet medical need for a particular patient population with serious and lifethreatening diseases or conditions when compared with state of the art. In alignment with the MDR and IVDR, this guidance presents recommendations for...