Resource constraints facing global manufacturers are also being felt by Notified Bodies (NBs) across Europe, due to the additional requirements imposed by the new MDR/IVDR Regulations. Team-NB, the European notified body association, issued a position paper to express concerns about lack of resources and guidance to assist in meeting the certification deadlines.
The primary concern cited is that Europe faces a likely device shortagefor patients due to the more complex and longer certification processes required under MDR/IVDR. The demands are too great for the small number of MDR/IVDR designated Notified Bodies (NBs), with only 25 NBs for MDR, and 6 for IVDR, as compared with 51 NBs designated for MDD, and 21 under the AIMDD/IVDD Directives.
Team-NB identified the following four primary contributing factors, along with possible solutions, in the position paper adopted December 1, 2021:
Issue #1: Expiring AIMDD/MDD/IVD certificates: The majority of AIMDD/MDD/IVD certificates will expire in early 2024.
Grace period for expired applications, if MDR/IVDR application has been accepted by a NB.
IVDR transition period extension beyond May 26, 2024
Encourage manufacturers to apply for MDR/IVDR certification early
Shorten MDR/IVDR designation time for NBs, to increase NB availability
Issue #2: Lack of authorization and harmonized “best practices”for MDR/IVDR remote audits.
Authorization for remote audits for MDR devices since the application deadline has already passed, and also for IVDR devices since the deadlines for 90% of IVDR devices is fast approaching.
NBs to conduct Initial and Surveillance MDR & IVDR remotely using a justified risk-based approach, and not only under “risk of shortage conditions”.
Issue #3: Over 80% of clinical studies have been disrupted or halted during the pandemic, leaving NBs at a loss for sufficient clinical data to conduct post-market follow-up activities.
Allow PMCFactivities that began under MDD, and were disrupted by the pandemic, to continue under MDR.
Allow remote surveys, remote assessments, alternative clinical/performance data to be considered for PMCF/PMPF/clinical activities impacted by Covid-19.
Allow adjustment to follow-up intervals for clinical studies impacted by Covid-19.
Issue #4: Lack of harmonized guidances
Team-NB requests permission to create harmonized “best practice” guidance, specifications, standards, and reference documents where EU guidance is missing.
Since the position paper was issued in December, the European Parliament reacted with an amendment to the IVDR that took effect Friday, January 28, 2022.
Extension of the transition period for IVDR certification of devices to alleviate burden on the NBs and ensure fewer device shortages.
Class D devices- May, 2025
Class C devices- May, 2026
Class B and A sterile devices- May, 2027
‘In-house devices’- May, 2024
Devices with no equivalent device on the market- May, 2028
Criterion Edge Can Support Your Push to MDR or IVDR Compliance
If your organization needs support getting your technical documents ready for the transition to MDR or IVDR during this ever-changing landscape of medical regulations, Criterion Edge has the expertise and bandwidth to work with you and get the job done. We have expert medical writers to support your organizations in developing the necessary documents to ensure a smooth transition and meet these fast-moving deadlines. Get a free consultation today.
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