IVDR

The European Parliament, by publishing the EU 2022/112 Regulatory, modified the transitional periods, initially foreseen by IVDR art. 110, as following: [...]

The goal of the “Sell Off” provision (IVDR art. 110 para 4) is to reduce the amount of time in which [...]

In most cases, Class A devices can be self-certified, unless they are sold sterile, while for Class B, C and D [...]

Manufacturers of in vitro diagnostic Medical Devices must face important news provided for in the Regulation on in Vitro Diagnostic Medical [...]

When the transitional period will end, all the IVDs to market in the European Union will have to satisfy the requirements [...]

In Vitro Diagnostic Medical Devices Manufacturer, according to risk classes, have the following transition periods available for the application of IVDR [...]

The in Vitro Diagnostic Medical Devices Regulation(EU) 2017/746 IVDR rules the in Vitro Diagnostic Medical Devices marketing, provision, and commissioning on [...]