VDI 5710 Blatt 1:2017-05

This standard represents a guideline and gives recommendations on the necessary steps required for the CE marking (conformance assessment) and the implementation of new nanotechnologies in the area of medical technology to fulfil the regulatory demands of the different laws and regulations. It enables the user to recognise arising problems during the licencing process in an early stage in order to take suitable measures. In Germany and within the EU special regulations apply to the use nanoparticles in medical technology products, medicines, foods and cosmetics. The standard applies exclusively to medicine products which which are subject to the medical device directive 93/42/EEC.