The NANDO database has a new Notified Body under the IVDR!
MDC MEDICAL DEVICE CERTIFICATION GMBH is the 9th EU Notified Body notified under the Regulation (EU) 2017/746 on in vitro diagnostic medical devices – IVDR.
MDC MEDICAL DEVICE CERTIFICATION GMBH
Kriegerstrasse 6
70191 STUTTGART
Country : Germany
Phone : +49:711:253597 0
Fax : +49:711:253597 10
Email : mdc@mdc-ce.de
Website : http://www.mdc-ce.de
Notified Body number : 0483
Here below, a short extract what the Notification covers:
Devices intended to be used for blood grouping:
- IVR 0101 Devices intended to determine markers of the ABO system [A (ABO1), B (ABO2), AB (ABO3)];
- IVR 0102 Devices intended to determine markers of the Rhesus system [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)];
- IVR 0103 Devices intended to determine markers of the Kell system [Kel1 (K)];
- IVR 0104 Devices intended to determine markers of the Kidd system [JK1 (Jka), JK2 (Jkb)];
- IVR 0105 Devices intended to determine markers of the Duffy system [FY1 (Fya), FY2 (Fyb)];
- 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;
Also, the following limitation should be taken into account:
- IVS 1005 Devices in sterile condition: including: aseptic processing; ethylene oxide gas sterilisation (EOG); moist heat sterilisation; radiation sterilisation (gamma, x-ray, electron beam); thermic sterilisation with dry heat;
You can find the full scope of its designation on the following link.
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