The stress on the resources and expertise of the European notified bodies in taking on the assessment of the device component of higher-risk drug/device combination products is among the significant challenges the EU faces as it enters the implementation phase of its new medical device and in vitro diagnostic regulations (MDR/IVDR).
The new regulations, which entered into force in late May, place the notified bodies (NBs) much more squarely into the review process for drug/device combination and IVD products, and will mean that drug manufacturers and other companies that have not previously intersected with the NBs will now have to do so.
The role and workload of the NBs will be expanding even as their numbers have been shrinking across Europe (from 80 to 53 for devices) due to the heightened oversight they have been getting in the wake of some high-profile shortcomings in their auditing responsibilities – for example, involving substandard materials in breast implants.
The MDR requires the notified bodies to be “re-designated” against the new regulations – a critical step in the implementation process since products cannot be assessed against the new regs until this is done. The NBs can request re-designation as of the end of November. All existing medical devices that are certified have to reapply against the new MDR.
The new MDR/IVDR regulations were developed to allow the European regulatory system to provide better health protection as well as to better handle the new technologies and broadening array of combination/IVD product types that have been forthcoming since the existing regs were put in place in 1993.
They are also a response to the doubling of the size of the EU, as well as the inconsistent application of the directives across Europe, resulting in an unlevel playing field for manufacturers. Unlike directives, regulations are automatically in full force across the EU member states.
The transition period for the full application of the MDR regs is three years, to May 2020, while the IVDR’s is five years, to May 2022.