Quality medical translation will prove essential to effective e-labeling
New York,NY (PRWEB) March 07, 2012
Merrill Brink Releases New Comments: E-labeling refers to the electronic labeling of medical devices, including instructions for use (IFU), labels on devices themselves and other literature published by the manufacturer, as opposed to producing paper copies.
In the medical translation industry, medical field professionals need to keep a close eye on the development of e-labeling, as should all medical device manufacturers.
Although e-labeling has been taking place for some devices since the MEDDEV guidelines on the subject were published in January 2007, the regulation has remained somewhat fragmented. Even after a further directive (2007/47/EC) was issued later the same year, e-labeling was still very much reserved for use with in vitro devices. This is because e-labeling has traditionally been considered as suitable only for devices that are used by experienced medical practitioners.
However, all this is about to change as a result of a draft regulation on e-labeling issued by the European Union on 8 June 2011. The regulations are intended to form part of the World Trade Organization Technical Barriers Trade activities and could be introduced later this year.
The regulations will introduce the scope for more e-labeling, under some very tight restrictions, for other devices, aside from just those used by medical practitioners. The regulations set out a number of conditions in which e-labeling may be acceptable, although paper versions of all materials should be available upon request and within a certain time frame.
There are several clear factors that manufacturers need to consider when looking at the option of introducing e-labeling. Access is a major factor and the EU is keen, in its draft regulations, to ensure that a full risk assessment is carried out by manufacturers to decide if e-labeling is appropriate to certain devices in specific environments.
Manufacturers are expected to have knowledge of the intended user and to make sure that they have access to the required technology, be it hardware or software, to view the e-labeling as it is intended to be viewed. The provision of back-up is another element to consider, in addition to the time frame in which paper alternatives can be produced and issued.
When considering moving onto e-labeling, manufacturers need to ensure their life sciences translation is of the very highest quality, which is where Merrill Brink’s medical translations come in. Our medical linguists are all subject matter experts and we have experience in producing accurate and consistent translations, which are vital when producing e-labels.
Many manufacturers may consider providing additional e-labeling in the form of e-information that is available alongside printed information. In this case, the EU regulations rule that the two forms must be “consistent” with each other and the importance of a high quality life sciences translation service is of utmost importance in achieving this level of consistency.
Merrill Brink is the only medical translation service provider with all five vital ISO and EN certifications: certified to ISO 9001:2008, ISO 27001:2005, ISO 13485:2003 and registered to EN 15038:2006 and ISO 14971:2007. Merrill Brink has proven experience and in compliance with international business and regulatory standards such as the European Union Directives, CE Mark requirements, Japanese Pharmaceutical Affairs Law and FDA regulatory programs.
The fact that our services include expertise in translation, risk management is particularly attractive to manufacturers looking into their obligations when providing e-labeling. The new EU regulations are bound to increase the opportunity for this modern way of displaying medical information, but it also comes with a range of risks that working with experts like ourselves can help to mitigate.
About Merrill Brink International
Merrill Brink International (http://www.merrillbrink.com) is a leading provider of complete translation and language solutions for global companies and law firms, with special expertise in serving the legal, financial, life sciences, software, heavy machinery and corporate markets. A proven leader with more than 30 years of experience, Merrill Brink offers a wide range of language solutions including translation, localization, desktop publishing and globalization services.
Merrill Brink is recognized in the industry for its commitment to quality and its pioneering approach of leveraging technology to reduce costs, eliminate redundant processes and accelerate translation life cycles. Merrill Brink is certified to ISO 9001:2008; ISO 27001:2005 and ISO 13485:2003, and registered to EN 15038:2006 and ISO 14971:2007. Together, these standards provide assurance that the most stringent process and quality standards for translation are followed. Merrill Brink International is a wholly owned subsidiary of Merrill Corporation.
About Merrill Corporation
Founded in 1968 and headquartered in St. Paul, Minn., Merrill Corporation is a leading provider of outsourced solutions for complex business communication and information management. Merrill's services include document and data management, litigation support, language translation services, branded communications programs, fulfillment, imaging and printing. Merrill's target markets include the legal, financial services, insurance, healthcare and real estate industries. With more than 5,000 people in over 40 domestic and 22 international locations, Merrill empowers the communications of the world's leading companies.
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