While the date of application of the new European Medical Device Regulation (MDR) has been postponed from May 2020 to May 2021, the new European IVD Regulation (IVDR) is still scheduled to come into force on May 26, 2022, in line with the original plan. When implementing the new regulatory framework, manufacturers are dependent on the early provision of infrastructure and detailed specifications, as the (re-)certification of tests is time-consuming. There have been significant delays here in the wake of the coronavirus pandemic. A postponement of the IVD Regulation is therefore also urgently required.
One year before it comes into force, the necessary infrastructure is not in sight:
- Political decision-makers and authorities are, of necessity, focusing all their efforts on combating the pandemic. The prioritization and resources required to implement the IVD Regulation are therefore lacking.
- The postponement of the MDR by one year was right, but exacerbates the problem for in-vitro diagnostics. This is because the consecutive entry into force at two-year intervals was intended to equalize the various system changes. It is now to be feared that the bow wave of MDR implementation will put massive pressure on preparations for the implementation of the IVDR. However, the resources of the authorities and notified bodies are not duplicated.
- Of the more than 20 notified bodies in Europe to date, only four are currently recognized under the IVDR regulations. Unlike the updated MDR, the future IVDR is largely a new version. While around 15 percent of all in-vitro diagnostics are currently certified by a notified body, this figure will rise to almost 90 percent in the future. A six-fold increase in the number of products will therefore meet an 80 percent reduction in the number of notified bodies.
The time remaining until May 2022 will no longer be sufficient to place diagnostic tests on the market in accordance with the new legal requirements and with the involvement of a notified body. This will have an impact on comprehensive healthcare provision with diagnostics. The situation is particularly critical for highly relevant areas of care such as personalized medicine and infection diagnostics. However, routine diagnostics, which are needed by millions of patients every day, are also at risk.
Diagnostics companies now need planning certainty in order to be able to supply the German and European markets with all the tests they need. A political decision on the date of application of the IVDR must be made in the first half of 2021.
In the fight against the COVID-19 pandemic, political decisions are just as necessary as the rapid availability of elementary and effective weapons against the pandemic (vaccines, medicines, tests, protective equipment). It has been shown that accelerated approval procedures are suitable for making appropriate products available to healthcare providers in the required quality when urgency is required. Emergency or special approvals are explicitly intended for such circumstances. In Germany, there is comparatively little willingness to implement rapid approval procedures. It is suggested that the regulatory requirements should be critically reviewed and made less bureaucratic, particularly for near-patient testing and tests for self-testing.