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EU MDR : 3 Best Practices for Multilingual Compliance

As the EU MDR regulation marches closer, medical device manufacturers are implementing strategies and identifying gaps in their current processes to be compliant with the new regulations set to go into effect on May 26 2020. These seismic changes are complex and have far reaching requirements impacting entire organizations from safety, clinical, regulatory affairs and more.

Language plays a pivotal role with EU compliance in particular as it relates to labeling and other content required for patient safety. With the enormity of documents requiring translation, medical device companies need confidence that resources and qualified language professionals be available when needed. In this blog series, we will discuss three best practices that you should consider to meet the MDR language requirements and strategies you can use to address language compliance starting with translations resources.

Scalable language resources

With the EU composed of 27 member states and 23 official languages, each member state may have different language requirements for labeling, some may require medical device labeling in their official language regardless of whether the device is intended for layperson or professional use. As our economy becomes more global and medical devices companies expand beyond their borders to market their products, the need for advanced language skills is rapidly growing. Specialized, medical translators are in high demand, everyone is competing for the same limited resources.

As a medical device manufacturer, your ability to secure language resources for translating mission critical labels and documentation is paramount. Your plan for compliancy will rely on having qualified, and available resources to meet your translation needs. While you may already have a language service resources how confident are you that your organization can address the scope and scale of increased translation demands imposed by the EU MDR?

According to KPMG’s, Rajesh Misra, advisory principal in healthcare & life sciences, “without adequate planning and budgeting, EU MDR compliance efforts could lead to strained resourcing… causing barriers to get EU MDR compliant products the market.” Additional findings from the KPMG-RAPS EU MDR Survey published that past September, found that only 27% of medical device makers expect to be fully compliant with the May deadline for EU compliance.

With the majority of language providers relying on outsourced or contracted resources to provide services, many language providers could be fighting over those same resources putting your projects at risk. This can lead to losing CE mark certification, having to withdraw devices from the market, or delaying the introductions and launches of devices. Such outcomes would not only bring about incremental costs and financial distress, but would also potentially cause long-term damage to the business and reputation.  To guarantee EU compliance, partner with a language provider with dedicated in-house resources, who are trained in life sciences and your specialty and with expertise in all 23 official languages.

Content that resonates …. Regardless of user

Providing clear communications for intended users is another EU MDR requirement that impacts: IFU’s, product labels, implant cards and more so. The regulation states that health providers, patients and caregivers must be provided with product inserts and instructions to operate devices safely in the Member State language. In some instances, a summary for safety and clinical performance may be required to appear on your website to address reusable devices, medical device interaction and overdose risks.

It’s not just about words though, translating and interpreting, symbols and icons may also be impacted. Symbols that indicate a device as medical, containing hazardous substances, or indicate a device as single-use may need to be updated to ensure global comprehension. Delivering these specialized translation services requires both in depth technical/clinical knowledge with the expertise to create content for users with the appropriate literacy level in the member state language. Partnering with a language service provider who can meet these needs is critical for your organizations EU MDR compliance.

How SDL fits in

SDL is the world’s largest non-governmental employer of translators, with over 1,300+ full-time employee translators in 59 offices, providing services for 19 of the top 20 medical device manufacturers.  With our in-house network of medical translators, SDL can scale to meet your EU MDR translation needs– while other LSP’s have to rely on the goodwill of freelance translators. With expertise in 30+ therapeutic areas, our in-house model not only helps us guarantee resources are available when you need them, but ensures content is technically and medically accurate and resonates with the intended audience - whether the user is a healthcare professional or a lay person.

To find out how SDL can support your localization and compliance strategy, please visit our MDR Solution Page, which can provide more insight on how we can support your regulatory needs.