On 15 july 2016, the european commission updated meddev 2. In this everchanging regulatory and international market clearance environment, it is vitally important for you to have this information at your fingertips. In most of those markets, accurate and compliant dfu and ifu translations are required when selling medical. Localization of medical device software, translation of resource files. Having spent most of his career working within the print sector and enterprise level labeling software, richard is always keen to learn about the regulatory labeling changes the.
Hello we would like to sell our ce marked class iii products in bulgaria. The translation requirement also applies to the eu declaration of conformity. Need fast and accurate translations of your medical device ifus instructions for. If software is not in hungarian, the screen texts must be in hungarian in the instructions for use. Transperfect medical device solutions is the worlds largest provider of language translation services and process automation technology to the medical device industry, with a. Every medical device must be accompanied by instructions for use, except medical devices in classes i or iia provided that the device can be used safely without instructions for use. Worse yet, when releasing new versions of your medical device, product labelling and ifus must also be updated, leading to continued translation spend. On this monitor there is a display of content in english ui do we need to translate this as well. Overview of the medical device regulatory market in greece. Once a medical device is granted with ce marking, it can be distributed in any of the european union countries. Ce marking for european directives the language center.
Translating medical devices of the future libor safar t traditionally, medical device industry translations are considered exceptional compared with the best practices of industries such as it, and for good reason. Stepes understands these medical device translation requirements and our years of localization experience, coupled with our vast quantity of preapproved medical translators and subject matter experts, allow us to deliver the highest quality medical device translation services ondemand. Looking for online definition of ifu or what ifu stands for. Best practice when preparing a medical device for compliance in foreign countries.
We provide certified translation of ifus in over 70 languages and in all european languages. Medical device translation services language scientific. Mandatory language requirements for medical devicesupdate. As a medical device manufacturer, importer or distributor it will be critical to have a good understanding of the new regulations.
If you want to create ifu for medical devices you need to be aware of both. These documents can include labels, instructions for use ifu and. Our iso certified quality management system and use of medical device expert linguists separate us from the rest of the translation world. The updated version replaces an earlier version of meddev 2.
Medical device ifu instructions for use translation. In a lifeordeath situation, the most current instructions are critical for patient safety. Medical device documentation best translation practices. Requirements for labelling, instructions for use and. Countries within asia, south america, and the middle east also have similar requirements.
Countries within europe have specific european translation requirements for computer software, instructions for use ifu, packaging, and other medical device and pharmaceutical labeling. Healthcare product manufacturers are required to produce and provide instructions for use ifu documents for their reusable surgical instruments, medical devices and. Professional japanese linguist specialised in medical. A guide to developing usable instructions for use for. Luckily, what needs to be included in the instructions for use for medical devices has been determined in. Hi all we are a small medical device company starting to sell in eu i understand that we have to translate our ifu to each country language. Requirements for labelling, instructions for use and language. Mandatory languages requirements for medical devices update sept. Ifu is listed in the worlds largest and most authoritative dictionary database of abbreviations and acronyms the free dictionary. This must be evidenced by the manufacturers risk analysis.
Susanne beckert january 25, 2017 the new european medical device regulation mdr gives great importance to the information supplied by a manufacturer to the end user to assist with the safe and proper use of a medical device. Mandatory language requirements for medical devices. Translation of medical device ifu gts translation services. How the mdr directive will impact packaging and labeling. Theres no underestimating the importance of instructions for use ifu documents. We have designed a number of internal standard operating procedures that dovetail with the requirements of european, asian and u. All of them have written the mandatory use of their own language for the information on the. Medical devices solutions transperfect life sciences. The one source for a world of translation services ce marking for european directives european regulatory language requirements ce marking on a product is a manufacturers declaration that the product complies with the essential requirements of the. The definitive guide to ifu for medical devices instrktiv. Medical device regulations when entering new international.
Mandatory language requirements for medical devices depending on the medical devices directive 9342eec mdd the member states of the european economic area, eea, can require their own language. Understanding the intricacies of medical device translation. Formal procedure for translation of consolidated regulatory text to all eu member languages. Companies with the staff, resources, and knowledge often have the ability to successfully maneuver through the intricacies of medical device translation, but even the largest companies may need to turn to translation agencies that specialize in the translation of medical and health science products. The elabelling regulation is only applicable to medical devices, not for ivds. The european mdr and ivdr require medical device manufacturers to publish user information on their websites. Deciding not to perform an ifu translation puts a medical device manufacturer at very. Nimus translates your ifu into multiple languages simultaneously in accordance with international rules. Translator profile yoko busk translation services in japanese to english medical. By dynamically, we mean using all of the tricks and tools available to your medical translation company.
Lets face it, quality ifu translation is expensive. Ifu translation for optimal userfriendliness nimus. In addition to ifu, stepes also translates device software, troubleshooting. Medical device labeling is any information associated with a device targeted to the patient or lay caregiver. Emergo analysis of european mdr and ivdr publication.
Medical device documents best translation practices globalvision. Previously, language requirements were the responsibility of each member state, but now there is a requirement that labeling. Localization of medical device software, translation of. Getting medical device labels, instructions and promotional materials ready for international markets can often be a daunting task.
Some of these cookies are essential to the operation of the site, while others help to improve your experience by providing insights into how the site is being used. Creating instructions for use ifu for medical devices requires quite a lot of responsibility in fact, you need to combine your techcomm skills with project management, administrative and legal skills. And this simple fact is why medical device manufacturers need to partner up with toptier medical and technical document translation services able to craft polished, and regulatory compliant medical device regulations. Medical device submissions, language translations, ifu.
The meaning of others will become clear with use or when viewed in the context of the device itself. What is the risk if my company decides not to do an ifu translation. Mandatory language requirements for medical devices basis. Important considerations for labelling of medical devices under the new eu mdr in european market, regulatory by dr. Labeling, ifu and translation may seem like minor issues compared to larger registration efforts, but the accuracy of the information supplied with your medical device is essential to avoid costly mistakes and market entry delays.
In this article, well answer your biggest questions about requirements and best practices for translating device labeling and instructions for use ifu. National laws relating to the medical devices directive 9342eec. If you wish to translate the software terms that is the user interface the medical teams will see on the screen, then it is. Mandatory languages requirements for medical devices. Medical device submissions, language translations, ifu, dsurs. Medical device labeling, ifu and translation for europe. Mandatory language requirements for medical device1. Medical device translation services gts translation services. Medical device labeling is supplied in many formats, for example, as patient. For professional use only, mdd and ivd software is accepted in english or german according to the wish of the user.
It is intended to help assure that the device is used safely and effectively. This is especially true if you have to translate instructions for use into multiple languages using the oldfashioned process. Ghtf sg1 definition of the terms medical device and in. It doesnt have to be registered in a country where it is going to be marketed registering a given medical device in greece allows for it to be distributed in germany, france, united kingdom or any other eu member state. Rws life sciences is the leading provider of translation solutions for many international medical device companies.
European translation requirements for medical devices. On may 5, 2017, the european commission released the new europe eu medical device regulations mdr in an effort to create a more unified and transparent system for medical devices the mdr will become enforceable in 2020, and introduces new rules relating to. The most important medical device markets in the world are australia, brazil, canada, chile, china, france, germany, italy, japan, mexico, spain, south korea, turkey, the united kingdom and the united states. Language scientific specializes in providing medical and scientific translation services to medical device companies. Symbols used with medical devices for use by other than healthcare professionals can require additional explanations. Luckily, what needs to be included in the instructions for use for medical devices has been determined in relevant legislation. Freyr help medical device manufacturers with language translation, editing of medical device technical information in ifu, dsurs, susars. Instructions for use ifu are therefore considered part of the product user interface. Richard castle, global account manager medical device, prisym id. On labels international symbols can be used as well as text in english e.
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