After a nine month wait, a seventh Notified Body has at last been designated under the EU’s new In Vitro Diagnostic Medical Device Regulation (IVDR). 3EC International a.s., a Slovakian certification organisation based in Bratislava, joins larger players such as BSI, Dekra and TÜV SÜD in being able to conduct conformity assessments for in vitro diagnostic medical devices (IVDs) under the IVDR. 3EC is already a designated Notified Body under the new Medical Device Regulation (MDR), and it was a designated Notified Body under the old Medical Device Directive and In Vitro Diagnostic Medical Directive.
With only three weeks to go until the Date of Application of the IVDR on 26 May 2022, after which all IVDs will need to be conformity assessed under the IVDR unless they benefit from the limited IVDR transitional provisions, any increase in Notified Body capacity is good news. However, the designation of 3EC does not really change the overall situation. As we have written previously, Notified Body capacity for IVDs is still far short of where it needs to be to tackle the increase in conformity assessment workload which the IVDR brings. The ongoing lack of Notified Body capacity represents a serious bottleneck for bringing new IVDs to market – and also keeping existing ones on the market.
This latest designation also does not indicate that the rate of increase of Notified Body capacity is meaningfully accelerating. As Amanda Maxwell writes in Medtech Insight (behind paywall), the last Notified Body designation under IVDR occurred back in August 2021, nine months ago, and the next designation is not expected until October 2022, still five months away. Meanwhile, due to the period of time which performing a conformity assessment requires, it is unlikely that 3EC will be in a position to start signing conformity assessment certificates until the latter end of this year.
Bluntly, the ship sailed long ago as regards sufficient Notified Body capacity to ensure a smooth rollout of the IVDR. Industry is going to have to make do with the small number of Notified Bodies which are available and whatever assistance the regulators are able to provide for quite some time. We all hope that the transition to the IVDR will not be too bumpy, but at this stage this is more hope than expectation.
Read the next article in this Spotlight on IVDR series: “Spotlight on IVDR – Why we keep banging on about Notified Bodies”
|Now that the IVDR is applicable, we will be publishing more articles taking a closer look at the possible impact of this revolutionary piece of legislation. We will be covering the challenges which adapting the new legislation will pose, the steps that regulators might consider to ease the burden on the MedTech industry, and any lessons that might be learned from the rollout of the MDR which took place one year ago. Watch this space.|
 Regulation (EU) 2017/746
 Regulation (EU) 2017/745
 Directives 93/42/EEC and 98/79/EC respectively.
 Or some fairly esoteric exceptions which are not worth mentioning here.