Fabian Demicoli

Economic Operators in the medical devices sector

For the sake of patient safety, in the era of global economy it is desirable to address adequate tracking and tracing of medical devices at a global level. One reliable way to achieve track and trace of medical devices is to develop a Unique Device Identifier (UDI). Such system will also improve fight against counterfeiting. In addition, the development of an international approach will make the trade of medical devices more secure for all the stakeholders.

 

Whilst it is already a legal obligation on economic operators to ensure they have in place an adequate traceability system, the EU is currently working with its international partners to develop an adequate mechanism for a UDI for each individual medical device. The most popular choices seem to be barcoding and radio-frequency identification (RFID). The mechanism chosen is aimed to be standardized and harmonized on a global level, meaning that it will probably not be the manufacturers themselves that draw up the barcode or RFID tag for their devices, but will be set out either by standardization institutions or specialized privately-owned approved companies that ensure that the codes/tags are truly unique for each device. Thus, it is expected that the unique codes will need to be bought at a cost.

In this regard, MSA kindly ask you to inform what impact (financial, administrative or otherwise) do you envisage on your operations and products should such system be introduced. It may be necessary to seek the opinion of your suppliers and business partners. Detailed replies will be greatly appreciated by the 31st January 2011. Email:

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