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Los códigos MD e IV que se utilizan en la designación de los Organismos Notificados se esta revisando y será el primer acto de implementación que se apruebe como consecuencia de los nuevos reglamentos. La Comisión europea ha publicado un borrador que ha recibido comentarios de distintas partes interesadas.

Los grupos de códigos son los siguientes:

MDA 01XX  Active implantable devices
MDA 02XX  Active non-implantable devices for imaging, monitoring and/or diagnosis
MDN 01XX Active non-implantable therapeutic devices and general active non-implantable devices
MDN 01XX Non-active implants and long term surgically invasive devices
MDN 02XX Non-active non-implantable devices
MDS 10XX  Devices with specific characteristics
MDT 20XX Devices for which specific technologies or processes have been used

IVR 01XX Devices intended to be used for blood grouping
IVR 02XX Devices intended to be used for tissue typing
IVR 03XX Devices intended to be used for markers of cancer and non-malignant tumours
IVR 04XX Devices intended to be used for human genetic testing
IVR 05XX Devices intended to be used to determine markers of infections / immune status
IVR 06XX Devices intended to be used for non-infectious pathologies, physiological markers, and disorders / impairments (except human genetic testing)
IVR 07XX Devices which are controls without a quantitative or qualitative assigned value
IVR 08XX Class A devices in sterile condition
IVS 10XX In vitro diagnostic devices with specific characteristics
IVT 20XX In vitro diagnostic devices for which specific technologies have been used
IVP 30XX In vitro diagnostic devices which require specific knowledge in examination procedures
IVD XXXX In vitro diagnostic devices which require specific knowledge in laboratory and clinical disciplines for the purpose of product verification

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