Translation of medical device labels: 8 steps
Do you want to translate your medical device labels but you don't know how?
We will share with you the steps to take to achieve this!
Índice de contenidos
Index of contents
Index du contenu
- But first you may be wondering what a medical device label actually is?
- You also wonder how it should be translated?
- Step 1: Gathering information on the medical device
- Step 2: Understand the regulations and requirements for medical device labels
- Step 3: Selecting a qualified translator
- Step 4: Checking the translation
- Step 5: Validation of the translation
- Step 6: Ensure clarity and understanding of labels for end users
- Step 7: Printing and applying the translated labels
- Step 8: Future label updates and changes
- Conclusion: The importance of following good practice in the translation of medical device labels
A medical device label is a label used to identify and inform users about a medical device.
This is written or printed information that is affixed to or in close proximity to the medical device.
In Regulation 2017/745 of the European Parliament and of the Council on medical devices, the term "label" is understood as: “the written, printed or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices".
A medical device is any health product (instrument, apparatus, equipment, etc.) intended by the manufacturer to be used in humans for the purpose of diagnosis, prevention, monitoring, treatment, alleviation of an illness or injury.
Labels are used to provide information on product characteristics, instructions for use, warnings, precautions and safety information.
First of all, you should be aware that the translation of medical device labels is a complex process.
It involves several steps to ensure the accuracy and quality of the translation, but also to ensure the safety and effectiveness of the devices.
It requires attention to detail and technical expertise to ensure that labels comply with regulatory standards and quality requirements.
Here are the 8 key steps you will need:
The first step you need to take in a medical device labelling translation process is to gather all the necessary information about the product.
Important information includes: user manuals, technical specifications and product drawings.
User manuals and technical specifications may include information on technical features, operating instructions, warnings, precautions and safety information.
Product drawings can help to understand the physical configuration of the product and to identify key elements for translation.
This is a crucial step. You must have all the information to ensure that you fully understand the product, so that the translation correctly reflects all the features and instructions for use of the product.
Once the information has been collected, you can proceed to step 2.
For this step, it is important to know and understand the regulations and requirements around medical devices and their labels.
This is a crucial step to ensure that the translation complies with regulatory requirements.
There are several regulations for the translation of medical device labels.
These regulations vary depending on the region where the devices are used and the category of device.
Let us share with you some examples of regulations affecting the translation of medical device labels:
- For the European Union:
Medical devices marketed in the European Union must comply with the standards of the European Regulation 2017/745/EU on medical devices.
Regulation 2017/745/EU of the MDR (Medical Device Regulation) came into force on 26 May 2021. It sets out the European rules for medical devices, and ensures the free movement of safe and effective devices.
Labels must be translated into at least the official language of the country where the device is marketed.
The Regulation requires that the labels of medical devices be translated into all official languages of the Member States where the product is marketed (up to 24 different languages).
- For the United States:
Medical devices marketed in the United States must comply with the Food and Drug Administration (FDA) standards.
Medical device labels must be translated into English.
It may also be necessary to translate them into other languages for the target populations.
- For Canada:
Medical devices marketed in Canada must comply with Health Canada.
Medical device labels must be translated into French and English.
- For China:
Medical devices marketed in China must meet the standards of the State Food and Drug Administration (SFDA) standards.
Medical device labels must be translated into Chinese.
So if you want to market your product in these parts of the world, you know what you have to do!
Once you have completed these two steps, you will need to move on to step 3.
This step is also crucial: the selection of a qualified translator to carry out the translation.
It is essential that labels are translated accurately to avoid mistakes that could lead to accidents.
For this, choosing a bilingual translator who understands the cultural nuances and linguistic differences between different countries is essential.
It is also important to choose a translator who has experience in the medical field and is able to understand the technical terms used.
It is important to choose a translator who has a good knowledge of medical terminology and regulations related to medical devices.
Also make sure you choose a translator who works with Computer Assisted Translation tools (CAT) and translation memory.
This ensures the quality and accuracy of the translation, and also facilitates the revision and updating of medical device labels.
For this, we advise you to use the services of translation agencies.
Translation companies such as AbroadLink Translations have a qualified team of native translators. They are able to translate labels into a wide range of languages and comply with regulations as well as ensure quality medical terminology.
In addition, these translation agencies work with state-of-the-art translation tools to ensure an accurate and quality translation.
This fourth step is to check the quality of the translation done for your medical device labels.
This gives you confidence that it is accurate and meets the quality standards required for medical device labelling.
In addition, it is important to note that translation errors can have serious consequences, including potential accidents or injuries to consumers.
Indeed, a wrong medical translation can lead to an incorrect use of the medical device. This can cause personal injury and even death to the user.
But that's not all...
It can also cause miscommunication between health professionals and users. This can lead to errors in diagnosis and treatment.
Do you understand why choosing a good translator is crucial?
It is recommended that the translation be checked by another bilingual person who is familiar with medical terms and regulations.
This ensures that all details are taken into account and errors are corrected before the medical device labels go into production.
For this stage, translation agencies are once again very useful!
Don't panic, we'll explain what these certifications mean...
The ISO 17100 standard requires that translations are checked and proofread by another qualified translator to ensure quality.
As for the ISO 13485 standard helps to ensure that regulations are respected, that customer requirements are taken into account, and that the activity and its associated risks are controlled.
Our translation agency carries out translations according to this standard using translators who are specialised in medical translation and who are accredited by specific training in medical translation or who have studied medicine or health care related studies.
So, once again, choosing a translation agency seems to be the best solution for you!
This 5th step concerns the validation of the translation made for the medical device label.
You should also be aware that labels must be validated and approved in order to market the product, so no mistakes are allowed.
Health problems are not the only problems that can arise if you translate your medical device labels incorrectly...
Poor translation can also lead to legal problems for manufacturers and distributors.
Medical device labels must be approved by the national regulatory authorities for each country where the device is marketed.
Regulatory authorities can impose penalties and even ban the marketing of the medical device if the translation of the label is not accurate or is incomplete.
In order to market your medical device in a foreign country, it is important to note that it is necessary to have a Marketing Authorisation Application (MAA) issued by the competent national authority of the country, as well as a declaration of conformity.
To do this, it is essential to consult national regulatory agencies to find out the specific translation requirements for each country.
You can then submit your labelling for acceptance before marketing the medical device.
A bad translation will lead to the refusal of the marketing authorisation.
But if you follow all the steps to the letter this will not happen!
For the next step, you should also take into account the cultural and linguistic differences of the future users of your medical devices.
Your translation must be understandable to them!
To do this, you need to ensure that medical device labels are clear and understandable to everyone, including patients and healthcare professionals.
In order for them to be so, the information they contain must be presented in a concise and easily understandable way. They should use simple language, with standardised medical terms.
You should also ensure that the labels contain all the key information related to the product, such as instructions for use, precautions for use, potential risks and emergency contact information.
To make medical device labels easier to understand and reduce language barriers, you can also insert visual information such as graphics, drawings, symbols and icons.
Please note that they must be internationally recognised!
Indeed, there are international standards for medical device labels, such as ISO 15223-1. It defines the general criteria for the design, production and valuation of labels in terms of legibility, durability and compatibility with medical devices. This standard lists the symbols to be used for medical device labels.
So if you want to put symbols on your products, make sure you comply with this standard!
In the Regulation 2017/745 of the European Parliament and of the Council on medical devices, Chapter III 23.1, we find these requirements: “The medium, format, content, legibility, and location of the label and instructions for use shall be appropriate to the particular device, its intended purpose and the technical knowledge, experience, education or training of the intended user(s) for whom the device is intended”.
Once the labels have been translated, checked and approved, it is time to move on to step 7: printing and applying them to the medical devices.
There are also precautions to be taken for this:
You need to ensure that the labels are printed on high quality, water, heat and scratch resistant materials that comply with quality standards and regulatory requirements.
Labels should also be printed using high quality inks so that they do not fade over time.
You must also ensure that your labels are correctly applied to the medical devices.
This requires the use of appropriate application methods that ensure that the labels remain in place, and also remain legible to all.
Regulation 2017/745 of the European Parliament and of the Council on medical devices also states in Article 10 that: “The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient”.
Please note that there are also regulations published by the US FDA or the European MDR.
Therefore, label manufacturers must follow their rules, particularly with regard to the size of the labels, their placement and the information about the product.
It is also stipulated that manufacturers must add their brand name and country of origin to enable users to know where the medical device they are using comes from.
And finally, now that your labels are applied to your products, there is just one last step!
Checking updates and changes to the product to ensure that the translation is always up-to-date and accurate.
Indeed, the translation of medical device labels is not an isolated process.
They need to be updated regularly to ensure that they remain in line with regulatory standards and evolving quality requirements.
To do this, you need to regularly monitor regulatory changes and quality updates to ensure that your labels are always compliant.
In Article 83 of Regulation 2017/745 of the European Parliament and of the Council on medical devices, it is stated that for each device manufacturers must "update the design and manufacturing information, the instructions for use and the labelling".
In order to detect any confusion related to the understanding of the labels, we also advise you to monitor the comments of end consumers so that you can correct them quickly.
In conclusion, the translation of medical device labels is a crucial process to ensure safety and effectiveness for users.
It is important to follow the appropriate steps to ensure that labels are translated correctly and comply with regulatory standards and quality requirements.
It is essential to choose a qualified translator with technical expertise to ensure an accurate translation that meets regulatory standards, such as translation agencies.
It is also important to ensure that they are clear and understandable to end users.
Regular monitoring of regulatory changes and quality updates is necessary to ensure that labels remain compliant.
By following these 8 steps, you can ensure that your medical device labels are translated correctly and comply with regulatory standards and quality requirements. This guarantees the safety and efficiency of your devices for the end users!
Do not hesitate to call on the medical translation services of our translation agency AbroadLink Translations!
So translating medical device labels is no longer a secret for you?
If you have any questions, please feel free to leave a comment below. We are always happy to answer your questions!
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Emeline PADIEU is a marketing assistant at AbroadLink Translations and holds a degree in Applied Foreign Languages in English and Spanish. She is currently in her second year of a Master's degree in Applied Foreign Languages, specialising in International Management, International Exchange Techniques at the University of Picardie Jules Verne in Amiens.