Medical device labelling: What is it & what are the requirements?

The term “medical device” covers a huge swathe of equipment used within the pharmaceutical and hospital sectors, from hypodermic needles to heart rate monitors. The official EU classification states that a medical device is “any instrument, apparatus, appliance, software, implant, reagent, material or other article” which is used in the treatment, diagnosis, monitoring or investigation of any disease, injury, disability or investigative procedure.

It is crucial to ensure that the end user—whether they be hospital staff or a member of the public—knows exactly what to do with any device. In particular, the utmost precision is required when it comes to medical device translation, as professionals around the world will need to know the correct way to use the equipment. As such, appropriate and accurate medical device labelling is essential.

What is medical device labelling?

Medical device labelling relates to any material which is packaged on or with medical devices. It is intended to identify the device, as well as give users all the required information related to how devices work, and how to employ them safely. This does not just include printed material, it can also refer to any audio or video products which accompany medical devices to explain how it should be used.

The labelling of medical devices has become more widely discussed in recent years, following the introduction of the European Union’s Medical Device Regulation (MDR). This was designed to tighten the standards of medical devices from the EU’s original Medical Device Directive (MDD), including improving the level of detail and accuracy of device labelling. The MDR began its “transition period” in 2017, and will be fully instated as EU law by 2020.

Why is medical device labelling important?

Medical device labelling is important because, without having clear, detailed, and accessible guidance to accompany all medical products, a user may be unable to identify or use a device correctly. This may result in the device being ineffective or misused in a way which could damage the product or even cause harm to the user. This is why guidelines around their standards are so significant, though in the case of MDR, ensuring that patients can understand medical device labelling also applies to the language in which it is printed.

Companies that manufacture medical devices are also likely to be servicing their products to users and medical institutions on a global scale, with over half a million different medical devices available in the European Union alone. This makes precise labelling all the more important as, if labelling is unclear in the original language, translations will simply make it harder for international users to recognise and operate them. Different countries—and even different regions within countries—will also have different requirements for medical device labelling. Therefore, companies will need to ensure that the labels on their products will be able to comply with this legislation and that their translators have an expert understanding of these legal needs.

What are the requirements for medical device labelling?

Ever since the World Health Organization established the Global Harmonization Task Force in 1993, there has been a worldwide push for increasingly regulated medical device labelling. This is a worldwide effort to gather information from as many countries as possible in order to standardise the way this information is disseminated to the public. This includes increased use of pictorial instructions to avoid any potential issues surrounding how medical device labels are translated.

Unlike the original MDD, the MDR regulations around medical device labelling insist that the pharmaceutical companies be responsible for all translations, rather than the EU member states themselves. This serves to ensure that all labels are “clearly comprehensible to the intended user or patient”, and failure to comply could lead to some 30% of medical products being taken off the market.

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