Achieving compliance with the new European Medical Device Directive by March 2010

Mandatory compliance is less than a year away. There is a buzz about the industry as we close in on the deadline to comply with the new requirements of the European Medical Device Directive. Directive 2007/47/EC drafted September 5, 2007 will amend Directives 90/385/EEC, 93/42/EEC, and 98/8/EC and will be a mandatory requirement on March 21, 2010. A major revision to the European Medical Device Directive is the classification of software. According to Directive 2007/47/EC, software will now be considered, itself, a medical device and will need to be translated.

It's all about liability! Adverse events have been reported regarding operators of medical devices containing software misunderstanding screen commands because they were not displayed in the country's official language. These adverse events resulted in injury to patients in most cases and death to patients in some cases.

Don’t risk your CE Mark. Because of these adverse events, auditors and notified bodies are strictly enforcing these new software requirements under the Directive 2007/47/EC. Manufacturers who do not comply may not receive the CE Mark and European market clearance for new products and risk losing approval for CE Mark and European market clearance for existing products.

The ISO 13485 impact- all notified bodies agree, this is not simply a case of making a few changes to the essential requirements of the directive. According to Haroon Atchia, Chief Executive Officer & Technical Director of Quality First International: "All CE Marking procedures, especially those required by the regulations or invoked by integration in an ISO 13485 Quality Management System for instance will require an update. For the conversion to be possible and to avoid a backlog resulting in potential failure to meet the deadline, manufacturers may wish to request a suitable transition strategy from their Notified Bodies."

"As companies are scrambling to meet the March 2010 deadline, time is of the essence," explains Hervé Rodriguez, President of Excel Translations. "This is why it is paramount for Medical Device Manufacturers (MDMs) to choose an ISO 13485-certified translation company to accompany them in this process."

Find out more about how this will impact your company by downloading this free industry report.

Excel Translations is the Market Leader in ISO 9001- and ISO 13485-certified Medical Translation Services. We provide the required hardware and software expertise as well as the in-depth knowledge of language, regulatory requirements, cultural nuances and taboos, and linguistic connotations to make the translated software application as functional for the foreign user as it is for the domestic user. Excel Translations' localization engineers routinely work with software resource and online help localization projects on Mac, Windows, NT, and Linux operating systems. Contact us for more information about our medical translation services.

Labeling: The Path to Global Market Clearance

Labeling Impact on Worldwide Market Clearance

There are a few methods manufacturers can use to properly label their products and successfully gain market clearances worldwide. These different methods require consideration of the time, cost, and risk involved for your company. Common to all of them is the requirement for translation of the labeling. For all major markets, and many emerging markets, the product labeling is required to be in the country's official language. Depending on your approach, your market clearance registration dictates where the responsibility for translation lies. Review and control of the finished label, and the risks involved if the translation is incorrect, are considerations that every manufacturer must factor into their market clearance planning.

For the methods described below there are certain import/export requirements that must be considered. Manufacturers based in the United States must either register the product internationally using the same product code used for their domestic registration, or they must register the product under a different product code for the Rest Of the World (ROW). Methods similar to the ones described below are applicable for many non-US manufacturers as well.

The following has been summarized and outlined in Labeling: The Path to Global Market Clearance-

• Methods commonly used for market clearance
• Commonly encountered labeling related issues
• Recommendations and helpful hints
• The industry's best practices

Excel Translations specializes in medical device labeling translation, diagnostic products labeling translation, pharmaceutical labeling translation, and life science labeling translation. Common labeling translation services include the translation of user’s guides, the translation of IFU, the translation of medical inserts, and the translation of user interface scripts. Contact us for more information about our medical translation services.