Today medical device translation is becoming less about choice, and more about necessity. Health care markets around the world have implemented extensive translation requirements for the translation of device safety documents, user documentation and supporting material. These requirements vary by both country and product and should therefore be carefully researched according to geographic location.
Medical Devices in Europe
There are three directives that regulate the sales of medical devices within the EU; these directives also determine translation requirements for the products. Among the directives, there are many similarities in the translation requirements, however, it is important to note that individual EU countries do have the authority to determine distinct requirements for medical devices. The three directives are:
- 93/42/EEC Medical Device Directive (MDD)
- The MDD covers a variety of medical devices.
- 90/385/EEC Active Implantable Medical Devices Directive (AIMD)
- The AIMDD specifically covers implantable medical devices.
- 98/79/EC In Vitro Diagnostic Medical Device Directive (IVDD)
- The IVDD covers devices used to test tissue, blood, and other fluids for diseases.
Depending on the device’s ability to cause harm to the patient, user or bystander, medical devices and accessories are defined in the EU directives as Class I through Class III. The translation requirements become increasingly more complex according to the classification. Higher-risk devices in Class II and Class III, as well as most Class I devices, need third-party certification and a registered EU representative. Classes are as follows:
- Class I Devices – Low Risk Devices
- Class II A and Class II B Devices – Medium Risk Devices
- Class III Devices – High Risk Devices
Importantly, CE marking is essential for promoting medical devices in Europe. CE is an abbreviation of a French phase “Conformité Européenne,” and indicates that the medical device manufacturer has conformed to the 98/79/EC Directive. Depending on device classification, to legally display the CE mark, the IVDD, MDD, and AIMD all mandate that manufacturers provide all labeling, information for usage, documentation, and marketing materials in the official language(s) of the end-user’s country. More on this can be found in Article 4, Paragraph 4, IVDD 98/79/EC.
Medical product and device manufacturers are also required to translate documentation relating to production, and quality assurance processes in the official language(s) of the country in which the procedures are carried out. More on these regulations can be found in Article 9, Paragraph 11 of the IVDD 98/79/EC.
The extent of the product’s presence in the European Union will of course determine which languages are necessary; currently translation into 12 languages may be required for one product’s labeling, documentation, and marketing materials in accordance with the IVDD and MDD, compliance with which is necessary to achieve the CE marking.
Undoubtedly, medical translation is a big challenge. Medical companies looking to promote their products in foreign markets should recognize the full benefits that translation can have on the success of their product and subsequently the greater security of their company. Complete medical translations demonstrate a professional attitude and add a sense of thoughtfulness and care to your core business. Furthermore, a product without proper translation has the potential to create product liability issues that could ultimately damage a company’s reputation or, worse, cause damage to the consumer.
What You Get with MoGi Group
Translating medical documents and medical terms cannot be entrusted to a single individual just because they speak the target language. MoGi Group employs translation teams with medical terminology specialists that understand the intricate terms of the medical world and can communicate effectively with the translator to ensure the message is delivered accurately in every language. Additionally, our translators are native speakers in your target language; they understand the market culture and the consumers and can ensure your message speaks directly to the consumer.
MoGi Group medical translation services acknowledge many areas of medical translation and will work with you to find the most comprehensive solution for your medical translations. Specifically, MoGi Group covers the following areas:
- Instruction manuals for medical professionals and patients
- Medical texts and brochures
- Medical equipment and software
- Medical glossaries
To ensure impeccable quality in all our translations MoGi Group employs project managers, translators with subject matter expertise, professionals in the respective field, and proofreaders for every medical translation project. These professionals are tested and selected based on MoGi Group prerequisites and matched to a job based on language and area of expertise.
A professional translator, specializing in medical translation, performs the initial translation process. A medical professional will then review the technical aspects of the translation, and the proofreader reviews the entire text for sentence structure, grammar and overall comprehension.
Term research is completed and glossaries are created to ensure that the terminology used for a translation is consistent with the terms already utilized by the client and the industry. All materials are made available to our clients at anytime and confidential materials are handled on a strict need-to-know basis.
MoGi Group can help you achieve all your medical translation needs and deliver the very best for your business and your clients. Our work is never complete until our clients are fully satisfied.
Wait no longer; contact us today for a free quote on your medical translation project.