• Regulatory House

IVDR - Commission proposal

In the context of the forthcoming effectiveness of EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR, Regulation), the European Commission proposes to extend the transitional periods for the placing on the market of devices under Directive 98/79 / EC on in vitro diagnostic medical devices. One of the main reasons is solving of the COVID-19 pandemic and at the same time the limited capacity of notified bodies, of which only 6 have been appointed so far according to the IVDR.

The proposed terms are described in this link.