Tools & Templates
EU Vigilance Requirements
Manufacturers are responsible for assessing any incidents that occur with their products on the market and determining if the incidents ...
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
We recommend bookmarking this page. The timeline is updated continuously, as new deadlines are announced or adjusted. Important Dates – ...
Declarations of Conformity
EU and UK Declaration of Conformity templates available for download in word format.
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 & ...