When is a medical device considered to be a medical device? – Certification, norms, and standards


Image: Computer keyboard where one key has been replaced by the CE symbol with the flag of the EU; Copyright: panthermedia.net/NiroDesign

Medical devices have to carry the CE symbol to be sold in Europe.

Image: Two people are looking at a coloured map of Europe in a folder; Copyright: panthermedia.net/thodonal

Getting a medical device certified according to different norms and standards is a ticket to new markets for manufacturers.