Originally Published EMDM
Originally Published EMDM
Makers of IVD products have until 7 December to ensure that their devices comply with the European Union’s In Vitro Diagnostics Directive (98/79/EC). Among other things, the directive requires manufacturers to show that they have a defined multilingual documentation process in place for their IVD products. The transition period for compliance with the directive began 7 June 2002 and ends in December. After 7 December, IVD products must have a CE mark in order to be placed on the market within the European Economic Area.
The directive outlines the multilingual documentation process, which includes translating the product’s packaging, end-user instructions, labels, and other collateral documentation. Translation is a difficult and time-consuming process, and device OEMs have been postponing the task for as long as possible. But the realization that time is running out has taken hold, as evidenced by a surge in demand for translation services from companies such as
Celer Pawlowsky S.L. (CPSL; Barcelona, Spain), a multilingual project management provider; and
Medilingua Medical Translations B.V. (Leiden, Netherlands).
“In the last four months, we have had a noticeable increase of inquiries from companies about our services,” says CPSL international business development manager Aidan Collins. “There are those who have made their plans and are ready to go, but there are others who just can’t get the wheels turning on this and are looking for our specialist help,” he adds.
Although time is of the essence, Collins neverthless cautions OEMs not to rush into a partnership without doing some homework. “Appoint one translation ‘owner’ within your company who has the power to coordinate all of the requirements,” says Collins. “That makes for a streamlined process.” He also recommends making sure that the translation vendor has proven experience in the IVD sector, and that a foolproof, preferably automated, way of tracking the process is in place. Before beginning the translation process, it’s also a good idea to “compile a master glossary of terms that has been signed off by the OEM with the help of in-country distributors,” Collins says. In addition, it’s important to insist on the use of in-country native translators, and if there will be a high volume of translation work, to seek advice on using computer-aided translation tools. “Over time, they can reduce translation costs,” explains Collins.
Medilingua managing director Simon Andriesen also stresses that manufacturers can “save time, cost, and energy, and avoid frustration, by making sure the translation is done right the first time. Companies should optimize the quality of the source text, use qualified people to do the work, allow sufficient time, and involve the in-country staff,” says Andriesen.
Since the IVD directive spells out which information should be provided in the local language, companies would be well advised to study the document in order to minimize their translation requirements. Andriesen suggests that companies split up the existing operating instructions, which have to be translated, and the reference manual with background information, which may remain in English.
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