Medical device labelling is a critical part of the medical device manufacturing process. Accurate labelling of medical devices is vital to ensuring market access, and the safe and proper use of medical devices by patients and care givers.
Labelling is one of the most heavily scrutinised parts of the product authorisation process (e.g. the CE marking process in Europe or the 510K process in the USA) and the cost of failing to correctly label a medical device or failing to include all the appropriate information can be significant for manufacturers.
Improper use related to incorrect or insufficient labelling can lead to product recalls or export bans, which bring with them financial penalties and potential reputational damage, while the omission of key information can cause costly delays to market entry.
What information is required on a medical device label?
The information that you need to include on your medical device labels is determined by which market or markets you are going to sell your product in. While regulations are becoming increasingly harmonised, markets still operate according to different standards and label requirements can vary according to country and region.
In short, the more markets that you target with your products, the more complex your labelling requirements become. For example, in the UK, according to the Medicines and Healthcare products Regulatory Agency (MHRA), medical devices must carry the CE mark and symbols for single use, while in the USA, the Food and Drug Administration (FDA) stipulates that additional information is included under the symbols.
In mainland Europe, including in the EU nations, medical label requirements must meet the stipulations set out in the BS EN ISO 15223-1:2016 standard and label information must be presented in the language of the market. In addition to English, there are 23 official languages of the EU. Information demonstrating compliance with relevant international ISO standards must also be displayed.
The new EU labelling requirements
The significance of labelling in the medical device manufacturing process is set to become even greater with the introduction of the new EU Medical Device Regulations (MDR), scheduled for 25 May 2020.
The MDR will replace the current EU Medical Device Directive and the Active Implantable Medical Device Directive, and is aimed at improving product quality, safety, reliability and performance by placing greater emphasis on clinical evaluations and data.
As a result, medical device manufacturers will have to supply more information. Part of this requirement relates to label information. Regardless of what happens with Brexit, if you want your products to be sold in the EU, they will have to comply with these new rules.
How to ensure that your medical device is labelled correctly
Medical device labelling requirements can be different and to avoid omitting key symbols and information, it is vital that you decide at an early stage exactly where you want to sell your medical device.
A clear vision and decision on target markets at this point will help you avoid having to make lots of different labels and incurring the related costs. If you intend to sell your medical device in multiple markets, you need to include all the relevant symbols and additional data, amalgamating this information where possible.
Whether your product will be sold in a single market or many, completing the essential requirements checklist will help you analyse what texts and symbols you need. This will ensure that you comply with all the appropriate regulations and satisfy the demands of the various regulators.
How a contract manufacturer can help with medical device labelling
The process of labelling medical devices can be complex and the launch of the new EU MDR is set to introduce new requirements and attach even more significance to the information that you include on your products.
By working with an experienced contract medical devices manufacturing partner, you will have access to expert guidance to help make sure that your products are correctly labelled and comply with the relevant regulations.
Specialist advice such as this should be one of the benefits of using a medical device contract manufacturer. If you are not getting this help, it’s time to reconsider your partnership.
Meridian Medical is an established and experienced contract medical equipment manufacturer, specialising in a wide range of medical device design, development and supply services.
To find out more about how Meridian Medical can help you with your medical product design and manufacture, get in touch today by filling out our online form or contacting us on 01903 732344 or info@meridian-medical.com.