;   Medical Translation Insight: New EU IVD regulations to cause translation headaches for device manufacturers - ForeignExchange Translations

New EU IVD regulations cause medical translation headaches for device companies
Attention IVD and medical device manufacturers: The EU has finally released the new regulations for in-vitro diagnostic products on the European market. The long awaited and potentially costly changes will cause much concern as is but there is one area device manufacturers may have yet to consider - language translations.

While some of these regulations may seem familiar given that they've been previously released as guidances, the European Commission is now requiring that device manufacturers and medical translation providers take notice, and implement these requirements to avoid delayed time-to-market.

There is a notable silver lining, however; with the initial documents being presented to the EU Parliament and Council of Ministers for review now, the adoption of these regulations will likely take place in 2014.

However, medical device firms shouldn't consider that a justification to wait to address these changes. In terms of translation, it's a blessing that companies have time to analyze and verify assets and documents. The process of getting medical technology product to market is already long and laden with in-country reviews and approvals. Now is the time to conduct a translation audit for existing translated materials. Device firms have the opportunity to verify the quality of translated documents now, as the EU is requiring them to adhere to the highest level of quality, and be able to certify your translations against proven ISO and EN standards.

Perhaps one of the most significant requirements in the new regulations is that all software content now needs to be translated. As regulatory professionals likely aware, this is a significant process that requires a long an in-depth audit of materials for localization.

As a medical translation provider, it's important that we test the user interface in a comprehensive manner, in addition to conducting all translations. The workflow for software translation is not a simple process, nor is it easily covered in your existing process for printed materials. It requires a translation partner with knowledge in the device software space, and the track record of successful CE marks and approvals in the EU.

Of additional concern should be the new required language submissions for all support documents. While the initial requirement states that to apply for approval, all support documents could be required in one of three official EU community languages (English, French, and German), it goes on in Annex 1 Section 17 to illustrate that additional submission might be required in any of the 23 official member states languages.

It's easy to see that the preparation time for all of this material translated across 23 languages might seem impractical, depending on the scope of a company's product. Having a translation provider armed and ready with a complete audit and inventory of materials and the ability to act quickly in translating IFUs and labels to the EU's specific requirements will ensure that submissions are approved on-time, without any additional areas of concern in this already challenging process.

No doubt: The European Commission is requiring a lot of medical device manufacturers in this new regulation. They are requiring that companies provide measured, quality translation across a submission, and a readiness to move quickly with translated documents for approval. It will be interesting to see this all roll out!


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