Jul 7, 2020

The European Commission made available a number of new resources for use during the pandemic, including a detailed report listing average Notified Body processing times for devices relating to COVID-19.

Survey of Notified Bodies reveals conformity assessment capacity

In the “Joint European Roadmap towards lifting COVID-19 containment measures” that was adopted on April 15, the European Commission made a commitment to gather and publish information on the availability and capacity of Notified Bodies to perform conformity assessments for medical devices and IVDs related to the diagnosis and treatment of COVID-19. In pursuit of this goal, the EC conducted a survey from May 7-13, sending questions to Notified Bodies about their processing times for different procedures and device classes. The results have now been released as a guide for device manufacturers and other economic operators.

37 out of the 55 Notified Bodies contacted responded within the stipulated timeframe; out of these, 16% indicated that they are not accepting any new applications for device certification, and 8% are not considering applications relating to a change notification. The report includes 22 graphs and divides up the data in terms of:

  • Initiating vs. completing a procedure
  • New certifications vs. change notifications
  • New clients vs. existing clients
  • Different device classes
  • Different Regulations (MDD, MDR, IVDD, IVDR)

List of essential devices for COVID-19, guidance documents, and database

The EC published a new “List of COVID-19 essential Medical Devices (MDs and IVDs),” which should serve as a guide for Notified Bodies when considering which products to give priority to for conformity assessments. Also available is the “COVID-19 In Vitro Diagnostic Devices and Test Methods Database,” which is described as a browsable repository of all publicly available information on CE-marked IVD performance, along with “in-house laboratory-developed devices and related test methods for COVID-19.”

Finally, two noteworthy guidance documents relating to the pandemic appeared:

Related European medical device regulatory resources from Emergo by UL:

Author

  • Timothy Herr

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