When MDR and IVDR were approved in 2017, it was foreseen that the MDR would enter into mandatory application on 26. 5. 2020 and the IVDR two years later, on 26. 5. 2022. This is linked to other preparations resulting from the new legislation. These include the preparation of the Eudamed database, the issuing of implementing acts and common specifications, the appointment of notified bodies, etc. Then there was the COVID-19 pandemic, and there was strong pressure to postpone the mandatory applicability date of the MDR by one year. This was done, but the deadline for the transition of all medical devices to the exclusive MDR regime, 26. 5. 2024, remained unchanged. In practice, this means that the manufacturers of so-called legacy devices have only had a shorter transition period from four to three years and that a large number of established medical devices will have a problem in the year 2024 with the lack of new certification according to the MDR.
Over the last year, there has been an intense debate on how to proceed with the implementation or deferral of IVDR, which can be expected to have similar or even more serious problems than those encountered in the case of MDR. First of all, it should be noted that about 80% of IVDs are still subject to so-called self-certification, where the manufacturer assesses compliance with the essential requirements on its own without the involvement of a notified body. The fact that it will now be mandatory for most IVDs to have a notified body appointed under the IVDR involved in the conformity assessment process represents a real revolution. Moreover, the very low number of such notified bodies to date clearly shows that there is a risk of an extreme excess of demand for certification services over actual supply.
The result of the EU-wide discussion is the adoption of the amending Regulation (EU) 2022/112, which does not postpone the mandatory applicability date and instead comes up with a model for the gradual implementation of IVDRs on a group-by-group basis. As of 26. 5. 2022, manufacturers of all new IVDs, as well as manufacturers of non-sterile IVDs belonging to Class A (the lowest risk class), must comply with the new rules. Manufacturers of "Legacy IVD" class D (the highest risk class), must comply with the new rules from 26. 5. 2025. One year later, on 26. 5. 2026, the Class C IVD wave will follow and finally, from 26. 5. 2027, the new rules will also be binding for Class B IVDs as well as for Class A sterile IVDs. The staggering of the implementation over time thus leaves the chance for a gradual even utilisation of the certification capacity.
Author: Jakub Král
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