Current Edition

The Impact of the New European Union Medical Devices Regulation (EU MDR) 2017/745 and MDR 2017/746

The European Economic Area (EEA) – which includes the European Union (EU) and three of the four states of the European Free Trade Association (EFTA) – has long been considered one of the largest global medical device markets. For device manufacturers, gaining and maintaining access to this important market is an obvious objective.  However, this also requires staying on top of regulatory changes to ensure timely product certification, says Sheena Dempsey at RWS.