The Covid pandemic has seen some significant disruption in the release and adaptation of new (and revised) regulatory requirements globally. None mores so than the release of MDR and IVDR.

We thought we would share some proposed amendments to the IVDR (Regulation EU 2017/746) around transitional arrangements moving from IVDD (Directive 98/79/EC).

The intent is to not overload NB’s with devices that will now require NB involvement under the new regulations.

This is particularly relevant to manufacturers with lower risk devices where assessment did not require the involvement of a NB (under IVDD) and DoC was completed before the 26 May 2022 that now requires NB involvement under the IVDR, the following transitional changes are proposed.

(a) 26 May 2025 for class D devices;
(b) 26 May 2026 for class C devices;
(c) 26 May 2027 for class B devices;
(d) 26 May 2027 for class A devices placed on the market in sterile
condition.

Post market and vigilance requirements of the IVDR shall remain in place.

Need to know more, Contact Us.