Regardless of type of IVD, there are certain common requirements to place your device on…
IVD’s
The Road to IVDR Compliance in Europe
Welcome to the realm of In Vitro Diagnostic Devices Regulation (IVDR) in Europe. As the…
5 things to know about EUDAMED registration
Covering the whole European Union, EUDAMED (European database for medical devices) is the European Commission’s…
Do you know the requirements for IVD legacy devices to be marketed on the EU and UK markets?
80% of IVDs devices that did not need to involve a notified body under the…
IVDR Compliance towards Korean/Chinese manufacturers
As an IVD (In Vitro Diagnostic) Korean manufacturer, accessing the EU (European Union) market can…
How to select a Notified body for your in vitro diagnostic medical devices?
Most in vitro diagnostic medical devices require the involvement of a notified body or approved…
Selling medical devices online in the EU
Complying with the rules on distance selling of medical devices and in vitro diagnostics device is a fundamental step when a manufacturer chooses to sell the devices online.