The in vitro diagnostics industry breathed a sigh of relief late last year when the European Union finalized a revised, staggered rollout of the incoming regulation. Yet, the new timeline has left old problems, from the shortage of notified bodies to the lack of some required documents.
Officials created the new timeline for the In Vitro Diagnostic Regulation after accepting that the "grave shortage of notified body capacity" was a threat to the continued supply of tests in the European Union. Three months have passed since the Commission issued that warning and the notified body situation is largely unchanged.
There are six notified bodies designated under IVDR, and all are located in three countries: France, Germany and the Netherlands. When it proposed the staggered rollout, the Commission said the concentration of notified bodies in three countries is "particularly problematic" for small and medium-sized enterprises in the other 24 EU member states because they "have a tendency" to work with notified bodies in or next to their home markets.
The situation is unlikely to improve quickly. As of the middle of December, no notified bodies, other than the six already designated, had reached the stage of receiving a final report from a designating authority. The final report is the seventh step in the 11-step process for designating notified bodies. One notified body was at the corrective action plan review stage, the sixth step, and another was one step back.
As 17 notified bodies have filed for IVDR designation, the EU could end up with close to the 21 bodies that are designated under the outgoing directive. However, while that bodes well for the long term, it is unclear if the capacity will come online in time to handle the waves of conformity assessments created by the staggered rollout of IVDR.
Stella Kyriakides, European Commissioner for Health and Food Safety, recognized the continued potential for disruption when disclosing the finalization of the staggered IVDR rollout late last year, telling member states, manufacturers and notified bodies that there is "no time to rest."
MedTech Europe raised similar concerns, telling EU regulators more capacity is needed quickly given that it can take up to two years to sign a contract with a notified body, complete the certification work and deliver the tests.
The timeline suggests manufacturers of higher-risk class D devices, such as tests for HIV and hepatitis, may have little more than one year to start the process if they are to meet the May 2025 deadline for complying with IVDR.
Notified bodies will be contending with a wave of Medical Device Regulation conformity assessments at the time the IVDR workload ramps up, with Team-NB finding most directives are set to expire in the first five months of 2024.
Writing after the staggered IVDR rollout was proposed but before it was finalized, the notified body association warned of "an extreme bottleneck in the processing of MDR/IVDR certification by NBs, which will increase towards 2024 proportionally to the amount to expiring Directives certificates and will most probably prevent high number of devices currently certified under Directives from timely transition by 26 May 2024."
The shortfall of IVDR notified bodies is compounded by the fact the certification process takes longer than for the directive, according to Team-NB.
European authorities are trying to flatten peak demand by encouraging IVDR manufacturers to file early for conformity assessment. This week, the Medical Device Coordination Group "strongly" encouraged manufacturers of COVID-19 IVDs based outside the EU to file an application for conformity assessment to a notified body "as soon as possible." However, with just six IVDR notified bodies capacity is limited.
Efforts to boost the stock of notified bodies will take time to deliver results, even if they ultimately result in sufficient supply to avoid a series of crises as the staggered implementation of IVDR happens.
Some of the other outstanding issues could be addressed more immediately. For example, the harmonization of remote audits between member states and the clarification of when a risk of a shortage is severe enough to permit the approach could help to improve access to notified body capacity.
Equally, there are still gaps in the documentation on the implementation of IVDR.
The staggered rollout means more IVDs will be on the market as legacy devices but some of the rules about that category of devices are unclear. Manufacturers can continue to ship IVDs allowed to market under the old directive, provided they do not make "significant" changes to their design and intended purpose. The definition of "significant" will shape when some IVDs need to comply with IVDR.
The MDCG created guidance on significant changes in MDR in March 2020. MedTech Europe wants to see guidance on significant changes in IVDR before the regulation takes effect in May so manufacturers know the consequence of actions such as switches of components in response to supply chain shortages.
