Our tool helps assess if a device change is non-significant, maintaining legacy status. Or if a change is significant, requiring ...

MDR/IVDR/UKCA vigilance reporting process for medical devices & IVDs in Europe, UK and Switzerland, plus Competent Authority contacts. Free and ...

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, ...

Important Dates – ALL For the purpose of this page, “Europe” = the EU-27, Iceland, Liechtenstein, Norway, Northern Ireland, and ...

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

Free EU MDR/IVDR Language Translation Tool. Confirm IFU translation requirements for medical devices & IVDs in Europe, UK and Switzerland, ...

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