Mandatory compliance is less than a year away (March 2010). 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.”
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