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NB designation and IVDR application date – the latest updates

Progress is being continuously made toward the application of Regulation 2017/746 EU on in vitro diagnostics, currently scheduled on 26 May 2022. At the end of November, another notified body was designated according to the IVDR, the German TÜV Rheinland, already designated as per Regulation 2017/745 EU (MDR). Although the number of designated NBs for the IVDR is stuck at 5, it should be noted that the European Commission has received designation applications from other 15 bodies. Some of these procedures are, however, still at an initial state.

In spite of the Covid-19 emergency, the date of application of the IVDR was not postponed – in contrast to what happened for the MDR. The situation is generating some worries for the operators of the sector, not only because the pandemic is delaying the implementation of appropriate measures by economic operators, but also because many tools that are critical to achieve conformity are still missing. These include common specifications, guidelines, and explanatory notes. The IVDR text also provides for some substantial changes in the classification and evaluation of the device conformity; the involvement of a notified body will be required more frequently compared to what happens today based on Directive 98/79/EC. This will inevitably translate into a greater workload for NBs, that would be currently unbearable.

The “Team NB”, a European association of notified bodies for medical devices, has recently expressed its views on this topic, by the publication of a position paper. With this document, it is clarified that the association will line up with the current timeline only provided that specific requirements are met:

  • The designation of at least 11 NBs as per the IVDR within the end of this year, i.e. half of those designated based on the Directive. It should also be considered that the designation of BSI UK will cease to be valid due to the Brexit (unless anything happens at the last minute), decreasing the current number to 4 bodies.
  • The availability of the appropriate tools required to perform the conformity assessment, such as guidelines, common specifications, expert panels etc.

In case these goals are not reached, the NBs would favour a postponement of the date of application. This measure, along with providing more time to make the missing adjustments, would prevent an excessive accumulation of audits in 2021, also because of the restrictions due to the Covid-19 pandemic. It should be added that the Team NB recommends that a decision is taken on any postponement of the date of application within the end of 2020 in order to minimise any impact for the interested parties.

The same position paper also examines an alternative proposal, that is to extend the grace period to class B and class A sterile IVDs with a certificate valid according to the current Directive. This measure could be introduced through a corrigendum, with a similar approach to that adopted on the MDR, and would allow these devices to stay on the market until 26 May 2024.

Written by: Riccardo Del Signore

Foto di mohamed Hassan da Pixabay