Manufacturers are responsible for assessing any incidents that occur with their products on the market and determining if the incidents ...

A PSUR is a stand-alone document created as part of a manufacturer’s post-market surveillance system. Find here free templates Casus ...

Find out which markets require registration for Class IIa, IIb and III medical devices, self-test and Annex II, List A, ...

We recommend bookmarking this page. The timeline is updated continuously, as new deadlines are announced or adjusted. Important Dates – ...

EU and UK Declaration of Conformity templates available for download in word format.

Free EU Labeling Language Tool. Confirm IFU translation requirements for medical devices & IVDs in Europe, UK and Switzerland, plus ...

Try our EU MDR 2017/745 classification tool (interactive flowchart). Download a free PDF of your results: EU device class & ...