IVDR: 6th Notified Body on NANDO!

The NANDO database is richer for a new Notified Body under the IVDR!

GMED SAS is the 6th EU Notified Body notified under the Regulation (EU) 2017/746 on in vitro diagnostic medical devices – IVDR.

GMED SAS
1, rue Gaston Boissier
75724 PARIS
Country : France

Phone : +33 1 40 43 37 00
Fax : + 33 1 40 43 37 37

Email : info@lne-gmed.com
Website : https://lne-gmed.com/fr

Notified Body number : 0459

Here below, a short extract what the Notification covers:

• IVR 0101 Devices intended to determine markers of the ABO system [A (ABO1), B (ABO2), AB (ABO3)]: Annex IX(I), Annex IX(II)
• IVR 0501 Devices intended to be used for pre-natal screening of women in order to determine their immune status towards transmissible agents: Annex IX(I), Annex IX(II)
• IVR 0504 Devices intended to be used to determine the infectious load, to determine infective disease status or immune status and devices used for infectious disease staging: Annex IX(I), Annex IX(II)
• IVR 0505 Devices intended to be used to grow/isolate/identify and handle infectious agents: Annex IX(I), Annex IX(II)
• IVR 0506 Other devices intended to be used to determine markers of infections/immune status: Annex IX(I), Annex IX(II)
• IVR 0605 Devices intended to be used for monitoring of levels of medicinal products, substances or biological components: Annex IX(I), Annex IX(II)
• IVR 0607 Devices intended to be used for detection of pregnancy or fertility testing: Annex IX(I), Annex IX(II)
• IVR 0801 Devices referred to in point 2.5 (rule 5), under a), of Annex VIII to Regulation (EU) 2017/746: Annex IX(I), Annex IX(II), Annex XI
• IVS 1001 Devices intended to be used for near-patient testing
• IVS 1002 Devices intended to be used for self-testing
• IVS 1003 Devices intended to be used as companion diagnostics
• IVS 1005 Devices in sterile condition (Limitations: – ethylene oxide gas sterilisation (EOG) – radiation sterilisation (gamma, x-ray, electron beam) – moist heat sterilisation – dry heat – aseptic processing – low temperature steam – formaldehyde sterilization)
• IVS 1009 Software that are devices in themselves including software apps, software for data analysis, and for defining or monitoring therapeutic measures
• …

You can find the full scope of its designation on the following link.

Days until IVDR is fully applicable: 280 days

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