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Does my product need to be traceable? What are my obligations?

2 October 2018 - 16:02

Medical devices are not standard products: they need to respect a set of norms before they can be commercialized. This means that they need to be traceable, from the beginning to the end of their life: their conceptualization and their production need to be followed very precisely and the same goes for the documentation linked to it, in order to ensure the standardization of the quality of the production. The need for traceability also has consequences for the production process, so it is better to anticipate whenever you want to launch yourself in innovation entrepreneurship in the health sector.

UDI (Unique Device Identifier),

In case of medical devices this traceability means the obligation of implementing UDI (Unique Device Identifier), used by different regulators in the world. It allows to identify in a unique way all medical devices, which leads to better manage the recall of defective equipment, reduce the number of medical errors, and it the end to increase the security for the patient.

The’ experts can help you to see the traceability process more clearly and can put you in touch with the specialists who can accompany you in taking all the right steps.

Make an appointment for a Traceability Session