Notified Bodies Raise Concerns With MDR Timelines

Regulatory NewsRegulatory News | 19 December 2018 |  By 

The European Association for Medical Devices of Notified Bodies (Team-NB) is explaining its immediate concerns with the new European medical device and IVD regulations, particularly as there may be an insufficient number of notified bodies to conduct audits and certify manufacturers and medical devices.

The implementation period leading up to May 2020 is “too short for all stakeholders,” especially since there are missing guidance documents that are necessary for the interpretation of specific requirements, the group said in a new white paper.

“Is it possible that all manufacturers and all products will be certified according to the new MDR before May 2020?” the paper questions, answering: “Most likely not – because the ‘new’ notified bodies will not be able to assess and take certification decisions for all applications before May 2020!”

The groups also explained how notified bodies must implement new procedures, hire, train and develop additional new resources for the new regulations, which cost time and efforts “that are not available.”

The result means that most manufacturers will need to make use of an extended grace period until May 2024.

“For manufactures of other than class I devices this makes it absolutely necessary to have valid MDD/AIMD-certificates available after May 2020 by applying from now on for renewal of the currently available certificates. This step will lead to additional workload on notified bodies desks and will hinder the acceptance of new product applications leading to a bottleneck in the whole approval process,” the paper adds.

On the IVD side, a shortfall of IVDR-designated notified bodies is also a concern.

In addition to the white paper, Team-NB released data concerning the present stages in which its member notified bodies are currently in under the framework of the MDR. Twenty-two of the group’s 24 members responded, and only two members have not submitted their applications yet to be designated against the MDR (and one member is merging with another notified body). Meanwhile, two members also said they are not in position to submit applications as the MDR has not been transposed into Turkish law.

One Year of Application

Surveys on MDR designation process steps


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