New IVDR Notified Body in Slovakia

New IVDR Notified Body in Slovakia – published in – 10 May 2022

After a nine-month delay, the EU’s new In Vitro Diagnostic Medical Device Regulation has finally selected a seventh Notified Body (IVDR).

New IVDR Notified Body in Slovakia
New IVDR Notified Body in Slovakia | Photo by Tetiana SHYSHKINA on Unsplash

3EC International From Bratislava Joins Names as BSI, Dekra and TüvSüd

At long last, another Notified Body has been established under the IVDR. 3EC International a.s., a Slovakian certification organization located in Bratislava, has been approved to undertake conformity assessments for in vitro diagnostic medical devices (IVDs) under the IVDR, joining larger competitors such as BSI, Dekra, and TÜV SÜD. 3EC is already a certified Notified Body under the new Medical Device Regulation (MDR) and the old Medical Device Directive and the In Vitro Diagnostic Medical Directive.

Notified Body Capacity is Still Far Behind

With only three weeks until the IVDR’s Date of Application on May 26, 2022, all IVDs must be compliance assessed under the IVDR.  Unless they qualify for the IVDR’s restricted transitional provisions, any increase in Notified Body capacity is welcome news. The designation of 3EC, on the other hand, has little impact on the overall issue: Notified Body capacity for IVDs is still far behind what is required to handle the increased conformity assessment burden brought on by the IVDR. The continuous shortage of Notified Body capacity is a major roadblock to bringing new IVDs to market, as well as maintaining existing ones on the market.

This recent classification also doesn’t imply that the rate of increase in Notified Body capacity is speeding up. The latest Notified Body designation under IVDR occurred in August 2021, nine months ago, and the next designation is not projected until October 2022, still five months away.

Smooth Transition to IVDR Seems to be Wishful Thinking

Straightforwardly, the ship has sailed in terms of having enough Notified Body capacity to ensure a seamless rollout of the IVDR. For a long time, the industry will have to make do with the tiny number of Notified Bodies that are available and whatever support the regulators can provide. We all hope that the transition to the IVDR would be smooth, but this is more wishful thinking than expectation at this point.

New IVDR Notified Body in Slovakia: Sources, Links and Downloads

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