In order to keep them available to the health care system and to patients, more than 85% of IVDs will need to be updated in view of the new in vitro Diagnostic Regulation (IVDR) which is at risk due to the ongoing COVID-19 pandemic. The remaining IVDR transition time is not sustainable and requires attention and effective solutions.
An exponential increase in swabs and serological tests, a continuously evolving demand for quicker and accurate diagnosis as well as for tests monitoring respiratory functions and diagnosing complications are some examples of the high pressure that the IVD sector had to face and has been responding to since the beginning of the COVID-19 pandemic.
IVD manufacturers have been on the frontlines of this fight, supporting Europe’s health services. They have invested in production, logistics, and expertise support to meet this challenge and have put research and innovation front and centre in order to define ways to identify the virus with increasingly effective methods.
COVID-19 is monopolising the scene, increasing the already existing challenges for the sector in implementing the new IVDR. It has diverted the resources of companies, institutions, and all parties involved, with the result of slowing down implementation.
The remaining transition time for the IVDR is no longer sustainable. The IVDR is scheduled to enter into full legal application from May 26th, 2022 – in merely 18 months from today. The key elements of the regulatory system have been substantially upgraded, especially the requirements for clinical studies and post-marketing ones, the role of notified bodies, and a new risk classification system.
However, the structural elements of the new regulatory framework have not yet been prepared. The guidance documents for new processes, such as on clinical evidence, are lacking. Expert panels and expert laboratories that are necessary to certify higher risk tests have not been set up. At the time of writing, there are only four designated notified bodies for more than 50,000 commercialised IVDs, compared to the 20 of the previous directive. It is a bottleneck that is difficult to overcome.
The impact of this regulatory change will be cross cutting. Companies, laboratories, laboratory medicine professionals, notified bodies and institutions are all involved at different levels.
Today, the IVD industry is aiming to draw attention to the issue and to ask for shared solutions among the stakeholders including the European Commission and the appropriate national authorities. The objective is to identify priority actions to ensure a successful transition towards the new European regulation, which the industry strongly supports, while not risking leaving the health system uncovered.
A possible solution could be to broaden IVDR’s so-called “grace period” to additional categories of lower risk class tests, as was done via the Medical Device Regulation corrigendum in December 2019. Another possibility would be to structure a gradual implementation of the IVDR in combination with the immediate strengthening of the existing IVD directive regarding safety and performance. And as done for medical devices to April 2020, calling for the official postponement of the application date only as a last resort.
