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  • Impact of a High-Quality IVDR Notified Body Application
    Ivdr

    Impact of a High-Quality IVDR Notified Body Application

    on 26 July 2022 | By Heike Moehlig-Zuttermeister, PhD, RQM+ VP Intelligence and Innovation, IVD

    The transition from IVDD (98/79/EC) to IVDR (EU 2017/746) has been overwhelming for many manufacturers, especially those that have never worked with a notified body because they were previously able to self-certify under the IVDD. Many are now realizing that the IVDR notified...

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  • Just Released: MDCG Guidance 2022-3 Verification of Manufactured Class D IVDs by Notified Bodies
    Ivd | Ivdr

    Just Released: MDCG Guidance 2022-3 Verification of Manufactured Class D IVDs by Notified Bodies

    on 17 February 2022 | By Heike Moehlig-Zuttermeister, PhD, RQM+ VP Intelligence and Innovation, IVD

    The MDCG guidance 2022-3 Verification of manufactured class D IVDs by notified bodies was issued earlier this week on the 15th of February 2022. This guidance is important for manufacturers because it provides a detailed specification of the requirements for the testing plan and...

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  • EU Update: Expert Panel Views for SARS-CoV-2 Devices
    Ivd | Covid-19

    EU Update: Expert Panel Views for SARS-CoV-2 Devices

    on 2 February 2022 | By Heike Moehlig-Zuttermeister, PhD, RQM+ VP Intelligence and Innovation, IVD

    The first three Performance Evaluation Consultation Procedure (PECP) views have been published for a professional SARS-CoV-2 immunoassay and a professional nucleic acid testing (NAT) assay as well as a near-patient testing NAT SARS-CoV-2 product. Considering the actual...

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