New EU Medical Device Regulations on Translations
The New EU Medical Device Regulations on Translations Are About to Hit… Is Your Company Compliant and Ready to Go?
In 2017 the European Union (EU) published a comprehensive list of requirements for medical device companies to produce and commercialize their medical devices being distributed to the EU market. A very important element in this is how companies are required to handle their translation submittals.
Starting in May of 2020, the Medical Device Regulations (MDR) will soon be strictly enforced. The deadline for compliance on these is slated for May 26, 2020. For a complete list of the EU Requirements please click here: www.eumdr.com.
WHAT DOES THIS MEAN FOR YOU?
Official Language Requirements:
The new EU MDR standards may impact your specific language requirements. To be compliant, the regulations state that all content must be translated into the 24 official languages of the EU member countries where the devices will be distributed. The official EU, languages in alphabetical order are:
Bulgarian, Croatian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Irish, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovene, Spanish & Swedish
Please note that while many countries have only one official language, some countries have multiple official languages. This means, for example, if your company is distributing its medical device products in Switzerland, they will need to be translated in each of their three official languages (German, French & Italian). If you have not already translated your documents into the 24 official EU languages, this may significantly increase the number of languages you will need to provide.
Timing of The New Requirements:
In the past, under previous regulations, translations were completed after the CE marketing. Under the new MDR, the translated content for Instructions for Use (IFU’s) and Product Labeling will be required much earlier in the process and are now considered as elements of the overall technical report that is submitted for review by the pertinent notifying bodies. What this means for you is that the timing and execution of the translations need to be made much sooner in the process. Your company will need to make the necessary adjusts in translation work flow management in order to be client to the new standards.
Content Requiring Translations:
The range of regulated medical devices has been expanded under the new MDR: products with non-medical purposes, are now included. In addition, translation requirements for devices currently regulated have been expanded greatly and are modified to include documentation from the manufacturer, analysis, marketing and management, authorization and distribution of medical devices. In the great majority of cases, existing technical documentation will need to be updated and revised to comply with the new MDR requirements.
Quality Management Systems:
The new MDR requires supply chain transparency relating to your quality systems and risk management. Your Language Service Provider (LSP) will need to support you with a highly effective and compressive Quality Management System that takes a risk-based approach to decision-making and management of 3rd party suppliers. Your LSP’s ISO 13485 certification is a critical and mandatory element that will demonstrate compliance in this regard.
Translation Quality Standards:
The new MDR requires very precise, non-ambiguous, and clear language, especially on content intended for the end user of the product. IFU’s, Labeling, IFUs, safety and clinical performance data must be clearly comprehensible and easily to understand for the intended user. This applies to the original source language and also to translated content. LSPs must give their translators additional training on this requirement and monitor their work to ensure compliant output.
Content Translation Management:
The new MDR puts a major focus on shared data and the use of a Central European database of medical devices, EUDAMED, to monitor, document, capture, compare and exchange device information in all of the 24 applicable languages. Considering the wide myriad of types and sources of this information, all revisions to existing technical documentation are required by the new MDR regulation. It is important that your LSP must be able to interact with client-based Content Management Systems (CMS) and have an effective Translation Management System in place to maintain accurate global changes, consistency in translations, transparency of work flow and end product translations, as well as cost-effective processes and work flow efficiency.
Choosing A Company for Your Medical Device Translations
The EU MDR website recommends that “one needs to consider the company or companies that will be developing, potentially producing and ultimately commercializing this product.” It’s essential to choose a translation company that is ISO 13485 Certified 13485 for medical devices. This means that the translation company has been through an extensive third-party audit for compliance specific to medical device work and are highly knowledgeable and experienced in translation deliverables and other details of the law, compliance & regulatory matters.
American Language Services (AML-Global) is ISO 13485 & 9001 Certified
AML-Global was once again awarded an ISO 13485 & ISO 9001 Certifications in 2019. We have been awarded these key accreditations for many years running and are proud of the great quality of cost effective, accurate and timely translations that we have produced over a long period of time for a wide variety of medical devise manufacturing clients who do business in Europe, Asia and around the world in dozens of languages.
Want to discuss your medical device translation needs? Reach out to us today at 1.800.951.5020
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