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, ...

Click here to see an overview of upcoming deadlines for medical devices and IVDs in the EU, UK and Switzerland ...

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 & ...