The translation for medical devices is big business. In the EU, the medical device business is worth 95 billion euros annually and provides employment for about 570,000 workers. The region has 24 official languages. Twenty-eight countries are members of the European Union. This is why the demand for medical device translation in the EU is huge. Still, the EU has standards covering the industry, which also affects the translation of materials in this sector.
Medical devices cover a broad range of materials, including plasters for wounds as well as pacemakers. The documentation for each of these materials is extensive. The term ”labeling” in this sector means the materials for advertising and marketing, instructions for patients and physicians and product labeling and packaging. It also includes the help and training materials that are of use to lab technicians, doctors, other medical professionals, caregivers and patients, and materials that describe each device clearly to anyone who uses it.
Medical device industry
The sector includes all the manufacturers of a wide array of products that serve people who have a variety of needs for healthcare. In 2017, the industry was worth about $434.4 billion. In the United States alone, around 6,500 manufacturers produce medical devices and its industry share is estimated to be about $155 billion in 2017. This is a sector that is expected to grow bigger, because it serves people around the world.
Exporting medical devices to new markets is one of the ways why this sector will continue to grow. The manufacturers must meet the requirements of the individual countries that were put in place by the local regulatory organizations. However, some of the regulations are not stable or even straightforward.
One of the top requirements is the translation of the product content. This includes:
- Instructions, labels, packaging, software and other marketing materials that the customer will use.
- Studies, certifications for quality management systems, paperwork for clinical trials and other documents related to the products that regulators need.
The European Union is one of the biggest consumers of medical devices and because of the number of member states and each country having their own set of requirements, it is quite difficult to launch a product into the region. Even the EU’s requirement for medical translation of all product content is not as straightforward as expected. Variations exist, as exemplified below:
Based on the Medical Devices Directive 93/42/EEC
In this instruction, the content that should be translated includes instructions for use, safety instructions, display and labels. The instructions and requirements under this differ by country as well. In the Netherlands, it is required that safety instructions, display and labels must be translated into Dutch. The instructions for use however could be exempt from Dutch translation if the manufacturers acquired permission that the device is for professional use from a Competent Authority.
Based on type of user
Some EU member states differentiate medical devices into ”public use” and ”professional use” and have different requirements for each. If the device is marketed in Finland, for example, it is a requirement to have the display and labels in English, Swedish or Finnish if the device is to be used by a professional. For public use, the display and labels must be in Swedish and Finnish.
The situation is different in Estonia. In this country, it is all right to use English for the labels intended for professional users. The display could be in English as well or in other languages as long as the potential user can understand it. This means that the manufacturer has to investigate what languages are spoken in the country and the size of the target audience in each language, making it difficult to decide which languages to use.
Based on languages spoken
Manufacturers will also have a difficult time in other countries where a number of languages are spoken. In Luxembourg, three languages are spoken, Luxembourgish, which the national language, German and French. For professional users of medical devices, content must be in English as well as in German or French. In Switzerland however, content should be available in three languages – Italian, German and French.
Standard for translation quality
The above are situations that every medical device manufacturer will face when exporting their products to the EU. Still, the region does have a set of standards that regulate the quality of content translation, which are published by the International Electrotechnical Commission (IEC) and the International Organization for Standardization (ISO).
This covers the quality management systems standards that medical device manufacturers and language services providers must meet. This means that all must be professionally done, and the suppliers should prove that all their procedures are documented.
This regulation provides guidance to vendors and buyers of translation services. It details the phases a translation project goes through and defines the quality needs that vendor and buyer must meet.
This replaces the EN 15038:2006 standard. This is specific to the language services provider and covers the central translation process of the translation company together with their project tracking and quality assurance systems. It covers various requirements that a translation services provider (TSP) must meet, including service procedures, contractual relationships between TSP and client, project management, quality control and human and technical services.
Growing need for medical device translation services
Medical devices are used all over the world and by itself it is a growing business as new markets continue to demand high quality products. In Latin America for example, Brazil is being hailed an economic powerhouse. It is one of the fastest growing economies in the world.
But every country has its own set of linguistic and administrative hurdles in the form of diverse and stringent regulations that must be met not only by the medical device manufacturers but also by translation agencies.
The amount of documents to be translated for medical devices is staggering to say the least. While regulations differ, the common theme is that content and materials that accompany any medical device such as patient-doctor-caregiver-focused documentation, marketing materials, software and user interface, instructions for use as well as labels and packaging must be translated into the required languages.
Every document that the regulators need to assess the device and later approve the importation and distribution of the products should be translated as well. This includes administrative documents, safety and effectiveness compliance, certificates of quality management systems, all tests and procedures, including clinical trials.
Different rules and requirements for translation
In most countries, medical device documentation should be available in the official language/s used in the country. However, it is not that simple as other countries allow some documents to be in English, such as medical device software that accompanies medical devices available in Bulgaria. Likewise, it is all right for medical device labeling for products available in Poland, Malta, Luxembourg and Cyprus to be in English, only if professionals will be using the medical device.
In Canada, the Guidance for the Labelling of Medical Devices says that the instructions for use of all medical devices purchased by the general public must be translated into the official languages of the country – French and English. However, this is true only during the time the device is bought.
Documentation for all other medical devices should be available in either French or English at the time of purchase, if the instructions should also be done in the other official language when the buyer requests it.
Israel’s national languages are Arabic and Hebrew. When it comes to the labeling of all medical devices, the country requires that the translation should be in Hebrew only.
Constant changes in regulations
Following the regulations of each country is already difficult and at times confusing. Another hurdle to overcome is the changes that continuously happen with the requirements for translation, including the complexity of terminology and medical procedures.
China is one of the largest markets for medical devices. In 2004, the country required that documentation for medical devices sold in China should have a Mandarin Chinese translation. In 2013, amendments to its initial rulings were published, which required that labels in Chinese must already be attached to the medical devices before the products enter the country or its territories. Changes to ensure the reliability and safety of the medical devices were added in 2014.
The Food and Drug Administration of Korea introduced new measures in 2012. The country established a system to certify medical device manufacturers from other countries, by either reviewing its documentation or through on-site inspection.
Day Translations, Inc. ensures that it keeps up to date with the latest regulations governing translation for medical devices. It conducts regular updates and requires its human translators to undergo training and continuing education. Medical translation is not simple. Day Translations wants to ensure all clients that with its strict project management process in place all medical translations are 100% accurate.
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