Tools & Templates

Periodic Safety Update Report Template

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

European Registration Requirements

European Registration Requirements

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

Declarations of Conformity

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

Language Requirements Tool

Language Requirements Tool

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

EU MDR Classification Tool

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