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Medical device recalls and labelling — a sticky issue

In 2018, nine percent of all medical device recalls globally were due to labelling errors, resulting in the return of over a million items. In the UK there have been three recall events of medical devices due to labelling errors since the beginning of 2019.

In Germany, over a ten-year period spanning 2005-2016, there were 1,155 recall events linked to deficiencies in the labelling and instructions for use.

Labels can become erroneous for a number of reasons, such as the wrong label on the wrong product, which can cause full batches to be recalled. In the EU especially, issues can arise with differing market information in line with local and international regulation.

In Europe, all medical devices and their accessories that have been placed on the European Union (EU) market since June 15, 1998, have had to comply with the essential requirements set forth by the Medical Devices Directive, including the CE mark and labelling requirements.

The year 2020 will see the introduction of the EU Database for Medical Devices (EUDAMED), which is expected to have major implications for the labelling operations of every manufacturer that trades in the EU — with every single label expected to be changed in line with the new regulations.

Yet despite this, many medical products continue to be recalled due to labelling errors. Why is this the case?

The main reason lies with contempt for automation, with tiresome manual labelling processes reigning supreme, exposing devices to the risk of human error. Upgrading to sophisticated automated systems seems logical, and as we move closer to EUDAMED, it seems an appropriate time for companies to consider their options.

In line with the new rules set out under EUDAMED, companies will have to include a lot more information on their labels, such as mandatory warnings and precautions, making instances of human error even more likely with each addition. Recall figures will only increase if companies don’t proactively review and strengthen their labelling infrastructure — and now is the time.

The costs associated with recalls are huge, and companies that adopt automated systems will reap the benefits of cost savings and greater efficiencies. As EUDAMED makes the process even more complicated, the potential human cost as a direct result of labelling errors must remain the priority for any organisation.

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