The EU IVDR regulation entered into force and was adopted on May 26th, 2017. Following a transition period of 5 years, it is all set to enter into application on May 26th, 2022. The regulation introduced several stringent regulatory requirements for IVD manufacturers and other economic operators. At the same time, it has intensified the role of the notified bodies. It also brings in the need of additional infrastructure such as EU reference laboratories for testing high risk devices, and the requirement of setting up of expert panels whose opinion is required during certification. In short, the change from the IVD Directive to the IVD regulation is a drastic one for all stakeholders and even requires certain infrastructure to be in place for its implementation.
With the application deadline approaching, the current situation shows that this infrastructure is not quite ready. It is estimated that around 70% of clinical decisions are made using IVDs. Around 80% of IVDs require notified body involvement under the IVDR. Currently, there are only six notified bodies which have been designated for carrying out IVDR assessments for the entire IVD industry and these are established in only three countries (Germany, France, and the Netherlands). Firstly, apart from this small number, they have limited capacities in terms of resources. Secondly, the EU Reference Labs required for the testing of Class D IVDs are yet to be designated. Thirdly, the EUDAMED implementation also experienced delays, but some modules are functional as of now.
On the other hand, the COVID-19 pandemic and the subsequent health care crisis brought in unprecedented challenges for the implementation of the IVDR since late 2019. The manufacturing industry has been badly impacted with several countries under lock down. To address the challenges put up by the pandemic, the manufacturers also had to redeploy financial resources to other priority areas. They ran into several challenges from facing shortages for raw material and other resources to working under constraints. In some cases, the manufacturers shifted priorities from IVDR transition to other activities like actually manufacturing COVID-19 kits.