Team-NB and NB-MED issued a White paper on the occasion of 26 November 2018 – 1 year after the designation process of Notified Bodies under the MDR/IVDR has started – summarizing the status and identifying six related concerns:
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Implementation period, May 2017 until May 2020, is too short for all stakeholders, taking into account that many details for both, manufacturers and Notified Bodies, are still under discussion;
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Missing Guidance Documents enabling clear interpretation of specific requirements;
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Unclear process behind the divergent opinions from the Joint Assessments;
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Unharmonized interpretations of the Joint Assessment Teams and the various member states
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Capacity shortage for some medical device codes;
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Workload for two legislative frameworks running in parallel for a period of time, from May 2020 until May 2024;”
The Notified Bodies also urge that it will not be possible to certify all the devices under the MDR before May 2020. Read the reasons here, or visit our online library of Useful documents related to the MDR/IVDR or consult Implementation tools for a smoother transition to the new Regulations !
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