MEDICAL TECHNOLOGY - UDI
Medical devices as defined by the directive are all those instruments, apparatus, equipment, materials and other items used individually or in conjunction with each other, including software used for the smooth functioning of the medical devices determined by the manufacturer for use on humans on the following purposes:
diagnosis, prevention, monitoring, treatment or alleviation of disease;
diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap;
investigation, replacement or modification of the anatomy or of a physical process;
control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. As defined by this directive, accessories are considered as independent medical devices. Further items defined as medical devices are:
Custom-made devices specifically made in accordance with a duly qualified medical practitioner's written prescription for particular patients;
Devices intended for clinical investigation in an adequate human clinical environment.
UDI directive for the labelling of medical devices
Unique Device Identification (UDI) is soon to become mandatory in Europe.
Despite the more complex processes, the advantages are obvious.
Manufacturers of medical devices can use the requirement for the clear labelling of medical devices by the FDA (Food and Drug Administration) in their company to their advantage by optimising procurement, logistics and production processes. UDI will also represent an important aspect in the field of QM.
Each medical device must bear a unique product number in future.
This must be applied to the product and/or packaging such that it is machine-readable (e. g. in the form of a 1-D or 2-D code or as a RFID tag).
Accordingly, the UDI comprises three parts:
The product data (UDI)
The data carrier (UDI carrier)
The database (UDID)
All three components must be taken into account as part of viable project planning and implementation.
This enables a much simpler targeted, product-specific traceability of medical devices than before (such as in the case of product errors or counterfeits).
(Unique Device Identification)
Normally, either the GS1 data
matrix code (bottom right) is
used as the 2-D code or the
GS1-128 is used as the 1-D code.
Both GS1 codes can encode
all the necessary additional
information and thereby uniquely
label the medical devices.
Existing non-disclosure agreements prevent us from
publishing project descriptions.
However, we will gladly meet to discuss your individual project.
In our projects, as a rule we use laser marking systems or labels printed by means of thermal transfer printing for applying the information.