In the sister piece to this article, MDR Notified Bodies – the stroll-out continues, we talked about the continued “stroll-out” of Notified Bodies to perform conformity assessments under the Medical Device Regulation (“MDR”). As we have reported previously, there is the exact same issue of low and scarcely increasing capacity in relation to Notified Bodies for the new In Vitro Diagnostic Regulation (“IVDR”) – but worse.
Since our previous update on Notified Body capacity in April, a further two Notified Bodies have been designated under the IVDR, bringing the tally to a meagre six. For context, there are 22 Notified Bodies currently designated under the existing In Vitro Diagnostic Directive (“IVDD”), so capacity for the IVDR stands at less than a third of the capacity under its predecessor legislation. This is with only eight months to go until the IVDR date of application on 26 May 2022, on which date the IVDD will be phased out and all new conformity assessments for in vitro diagnostic medical devices (“IVD Devices”) being placed on the EEA market will need to be performed under the IVDR.
What makes the IVDR situation so much worse than the MDR situation is that the vast majority of IVD Devices which are already on the market will move to a higher risk category under the IVDR. As a result, they will need to be conformity assessed by a Notified Body for the first time. It has been estimated that this “up-classification” of IVD Devices will increase Notified Body workload under the IVDR by 700%. It is hardly surprising that prominent figures in the European life sciences world such as the European Federation of Pharmaceutical Industries and Associations and the European Cancer Patient Coalition have called for a one year extension to the date of application and phased implementation of the IVDR to give more time to bring more Notified Body capacity online.
A recent survey from MedTech Europe really makes the scale of the issue clear. Based on responses from MedTech Europe members, who account for 90% of existing market revenue, the survey shows that:
- At least 22% of IVD Devices on the market today will be discontinued for the IVDR, and many more will be lost if urgent solutions are not found to address the difficulties of transitioning to the new regulations;
- The highest proportionate loss of devices will come from SME manufacturers;
- As of July 2021, certificates have not been issued for 88% of IVD Devices;
- 53% of IVD Device manufacturers do not have a Notified Body.
A Joint Implementation Plan for the IVDR released by the Medical Device Coordination Group on 7 June 2021 indicates that the European institutions are aware of these issues (and others) around the transition to the IVDR, and recognise the need for action to ensure essential IVD Devices are not lost from the market on the date of application. However, the recommendations in that plan to ease the Notified Body bottleneck are staggeringly weak, amounting to little more than “let’s have a think about how we can designate Notified Bodies in spite of COVID.” There is no indication at present that the European institutions are considering any extension to the Date of Application for any part of the IVDR.