Keeping track of traceability

The term 'medical device' is broad and covers a wide range of items. It is referred to most commonly as an apparatus or a piece of equipment that is used to treat or diagnose a condition that comes into direct contact with the patient. Whether it is a simple pair of contact lenses or a more sophisticated device, such as a pacemaker, the frequency with which we encounter medical devices in our day-to-day lives is surprisingly high and the key role they play in our well-being remains undeniable.

It is because of this role that regulations surrounding medical devices tend to be placed under more stringent scrutiny. Under the US Food and Drug Administration rule in the USA, manufacturers have been required to implement UDI (unique device identification) on all medical product packaging since September 2014. Following this, and in light of the recently adopted EU Medical Device Regulation, European manufacturers of medical devices will face tougher regulations to ensure that their products are safe to use under new EU laws that are scheduled to come into effect on 26 May 2020.

The new regulation will also see the introduction of a new, unique device identification system. This means that, for traceability purposes, medical devices sold in EU member states will need to include a code, also known as a unique device identifier, of which the details will be recorded in an EU database.

With these laws coming into effect, manufacturers now have a legal responsibility to invest in a solution that allows them to apply traceability codes onto products as well as their packaging.

As a global leader of high quality coding and marking solutions, Domino Printing Sciences is well placed to help these manufacturers meet the emerging requirements. The following white paper aims to identify the coding applications encountered most often in the medical industry and highlight the ways in which different coding and marking technologies are equipped to tackle them.