European notified bodies currently face significant stress on their resources and expertise. Completing assessments of the device component of higher-risk drug/device combination products is proving to be a significant challenge for the EU as it enters the implementation phase of its new medical device and in vitro diagnostic regulations (MDR/IVDR), according to International Pharmaceutical Quality (IPQ).
The new medical device and in vitro diagnostic regulations
The new MDR/IVDR regulations were rolled out in May, 2017. The 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.”1 Additionally, the regulations serve as a response to the EU’s doubling of size and the inconsistent application of directives across Europe. The transition period for full implementation of the MDR is three years (May 2020) and five years for the IVDR (May 2022).
Expanding workload for notified bodies
The new regulations position notified bodies (NBs) more into the review process for drug/device combination and IVD products than before. Consequently, drug manufacturers and other life science companies that did not previously need to interact with the NBs must now do so.1
The number of European notified bodies is shrinking (there are currently 53 for devices, down from 80). However, IPQ reports that the role and responsibilities of NBs continues to expand 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.” Additionally, 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… NBs can request re-designation as of the end of November [but] all existing medical devices that are certified have to reapply against the new MDR.”1
Pearl Pathways offers strategic regulatory consulting services for medical device and in vitro diagnostic companies. Learn more about how our experts can help you navigate the new MDR/IVDR regulations by contacting us today.