top of page
  • 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.

0 views0 comments

Recent Posts

See All

Which products cannot be registered?

SÚKL has published several types of products on its website for which it is no longer possible to apply for registration as a medicinal product, as they do not meet the definition under Section 2 of A


bottom of page