[FEATURED] Why EU Regulations Are Changing The Face Of Innovation And May Be Unsustainable
The EU must keep its medtech regulation under review as rapidly changing technology and external market factors may be challenging the operability of some aspects of the new medtech regulations, […]
[FEATURED] No Quick Fix When It Comes To EU MedTech Notified Body Designations
Latest information from the European Commission suggest that future notified bodies designated under the MDR, and even the IVDR, may not be in a position to issue certificates until March […]
[FEATURED] European Commission Publishes Draft Rules In Bid To Reclassify Non-Medical Active Products Latest Italian Designation Means Germany
The European Commission has launched an initiative to ensure products without a medical purpose that fall under the Medical Device Regulation are appropriately classified by risk, and subject to the […]