Tools & Templates
MDR/IVDR Legacy Devices: Significant Change Assessment Tool
Our tool helps assess if a device change is non-significant, maintaining legacy status. Or if a change is significant, requiring ...
EU Vigilance Requirements
MDR/IVDR/UKCA vigilance reporting process for medical devices & IVDs in Europe, UK and Switzerland, plus Competent Authority contacts. Free and ...
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
Find out which markets require registration for Class IIa, IIb and III medical devices, self-test and Annex II, List A, ...
Important Dates: Europe, UK and Switzerland
Important Dates – ALL For the purpose of this page, “Europe” = the EU-27, Iceland, Liechtenstein, Norway, Northern Ireland, and ...
Declarations of Conformity Templates
EU and UK Declaration of Conformity templates available for download in word format.
Language Requirements Tool
Free EU MDR/IVDR Language Translation Tool. Confirm IFU translation requirements for medical devices & IVDs in Europe, UK and Switzerland, ...
EU MDR Classification Tool
Try our EU MDR 2017/745 classification tool (interactive flowchart). Download a free PDF of your results: EU device class & ...