IVDR: 16th Notified Body on NANDO!

The NANDO database has a new Notified Body under the IVDR!

SGS Belgium is the 16th EU Notified Body notified under the Regulation (EU) 2017/746 on in vitro diagnostic medical devices – IVDR.

The Notification covers the following:

Devices intended to be used for blood grouping

• IVR 0106 Other devices intended to be used for blood grouping

Devices intended to be used for tissue typing

• IVR 0201 Devices intended to be used for tissue typing (HLA A, B, DR) to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration
• IVR 0202 Other devices intended to be used for tissue typing

Devices intended to be used for markers of cancer and non-malignant tumours

• IVR 0301 Devices intended to be used in screening, diagnosis, staging or monitoring of cancer
• IVR 0302 Other devices intended to be used for markers of cancer and non-malignant tumours

Devices intended to be used for human genetic testing

• IVR 0401 Devices intended to be used in screening/confirmation of congenital/inherited disorders
• IVR 0402 Devices intended to be used to predict genetic disease/disorder risk and prognosis
• IVR 0403 Other devices intended to be used for human genetic testing

Devices intended to be used to determine markers of infections/immune status

• IVR 0501 Devices intended to be used for prenatal screening of women in order to determine their immune status towards transmissible agents
• IVR 0503 Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents
• 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
• IVR 0505 Devices intended to be used to grow/isolate/identify and handle infectious agents
• IVR 0506 Other devices intended to be used to determine markers of infections/immune status

Devices intended to be used for non-infectious pathologies, physiological markers, disorders/impairments (except human genetic testing), and therapeutic measures

• IVR 0601 Devices intended to be used for screening/confirmation of specific disorders/impairments
• IVR 0602 Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease
• IVR 0603 Devices intended to be used for screening, confirmation/determination, or monitoring of allergies and intolerances
• IVR 0604 Other devices intended to be used for a specific disease
• IVR 0605 Devices intended to be used for monitoring of levels of medicinal products, substances or biological components
• IVR 0606 Devices intended to be used for non-infectious disease staging
• IVR 0607 Devices intended to be used for detection of pregnancy or fertility testing
• IVR 0608 Devices intended to be used for screening, determination or monitoring of physiological markers
• IVR 0609 Other devices intended to be used to define or monitor physiological status and therapeutic measures

Devices which are controls without a quantitative or qualitative assigned value

• IVR 0701 Devices which are controls without a quantitative assigned value
• IVR 0702 Devices which are controls without a qualitative assigned value

Class A devices in sterile condition

• IVR 0801 Devices referred to in point 2.5 (rule 5), under a), of Annex VIII to Regulation (EU) 2017/746
• IVR 0802 Instruments intended specifically to be used for in vitro diagnostic procedures referred to in point 2.5 (rule 5), under b), of Annex VIII to Regulation (EU) 2017/746
• IVR 0803 Specimen receptacles referred to in point 2.5 (rule 5), under c), of Annex VIII to Regulation (EU) 2017/746

Horizontal technical competence

• IVD 4001 In vitro diagnostic devices which require knowledge regarding bacteriology
  • Excluding Class D devices
• IVD 4002 In vitro diagnostic devices which require knowledge regarding clinical chemistry/biochemistry
  • Excluding Class D devices
• IVD 4003 In vitro diagnostic devices which require knowledge regarding detection of transmissible agents (without organisms or viruses)
  • Excluding Class D devices
• IVD 4004 In vitro diagnostic devices which require knowledge regarding genetics
  • Excluding Class D devices
• IVD 4005 In vitro diagnostic devices which require knowledge regarding haematology/haemostasis, including coagulation disorders
  • Excluding Class D devices
• …
• …
• IVS 1005 Devices in sterile condition
  • The following processes are covered: ☒ aseptic processing ☒ ethylene oxide gas sterilisation (EOG) ☒ low temperature steam and formaldehyde sterilisation ☒ moist heat sterilisation ☒ radiation sterilisation (gamma, x-ray, electron beam) ☒ sterilisation with hydrogen peroxide ☒ thermic sterilisation with dry heat ☒ Other sterilisation processes: chlorine dioxide, nitrogen dioxide, supercritical carbon dioxide
• …
• IVT 2011 In vitro diagnostic devices which require packaging, including labelling
  • Excluding Class D devices

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

SGS Belgium has been previously notified under the Regulation (EU) 2017/745 – MDR as well.

Are you looking for a notified body for your medical devices and IVDs? Contact us!

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