Danes check low-risk devices
This article was originally published in Clinica
Executive Summary
The Danish Medicines Agency, responsible for medical devices, has launched a surveillance programme for class I (low-risk) medical devices. These products are not subject to third-party certification by a notified body unless they are sterile or have a measuring function. The programme will involve spot-checks to ensure that manufacturers meet the requirements of the Medical Devices Directive (MDD), including product documentation requirements and setting up a post-market surveillance system.