EC names fifth notified body for IVDR
Regulatory News | 01 December 2020 |
The European Commission (EC) has announced designation of a fifth notified body for the European Union In Vitro Diagnostic Regulation (IVDR). TÜV Rheinland, the new notified body, was also designated a notified body for the upcoming Medical Device Regulation (MDR) in 2019. (Related: TÜV Rheinland becomes 5th notified body designated under MDR, Regulatory Focus 26 September 2019)
Implementation of MDR has been delayed by a year to May 2021 because of concerns about pandemic-related delays, but to date the IVDR deadline has stayed firm, with full implementation slated for May 2022; a grace period for devices with a valid IVDD certificate stretches to May 2024.
Though just 5 notified bodies have been designated for IVDR, a total of 15 applications had been received by EC by the end of October 2020. Most applicants are still in the early phases of assessment and review, however.
These figures are concerning to Team-NB, the European association of notified bodies for medical devices. In a 25 November statement, Team-NB made clear that the organization will only support sticking with the current timeline for IVDR implementation if at least half of the 22 current notified bodies are designated under IVDR by the end of 2020.
“The small percentage of IVDs currently subject to notified body assessment significantly limits the impact of the grace period as currently set,” wrote Team-NB in its statement. In addition to seeking to boost the number of notified bodies, the association is also calling for all necessary tools for conformity assessments to be “available and ready to use” by the end of the year if the current deadlines kept in place.
Team-NB proposes either extending the grace period or postponing the date of application of the IVDR if its two criteria cannot be met by the end of 2021.
NANDO
Implementation of MDR has been delayed by a year to May 2021 because of concerns about pandemic-related delays, but to date the IVDR deadline has stayed firm, with full implementation slated for May 2022; a grace period for devices with a valid IVDD certificate stretches to May 2024.
Though just 5 notified bodies have been designated for IVDR, a total of 15 applications had been received by EC by the end of October 2020. Most applicants are still in the early phases of assessment and review, however.
These figures are concerning to Team-NB, the European association of notified bodies for medical devices. In a 25 November statement, Team-NB made clear that the organization will only support sticking with the current timeline for IVDR implementation if at least half of the 22 current notified bodies are designated under IVDR by the end of 2020.
“The small percentage of IVDs currently subject to notified body assessment significantly limits the impact of the grace period as currently set,” wrote Team-NB in its statement. In addition to seeking to boost the number of notified bodies, the association is also calling for all necessary tools for conformity assessments to be “available and ready to use” by the end of the year if the current deadlines kept in place.
Team-NB proposes either extending the grace period or postponing the date of application of the IVDR if its two criteria cannot be met by the end of 2021.
NANDO
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