Many low-risk products fall short in Denmark:
This article was originally published in Clinica
Executive Summary
Many manufacturers of Class I or low-risk medical devices in Denmark have failed to register with the country's competent authority for medical devices, Laegemiddelstyrelsen, according to a survey carried out by the agency. The survey, which was designed to establish whether manufacturers are complying with the device regulations, also found that a significant number did not meet the Danish language labelling requirements, according to the industry association, DMDA.