The new European Union Medical Device Regulation (MDR 2017/745) brings significant changes to previous regulations. Device manufacturers who market products in the EU must be ready to meet the May 26, 2020 transition deadline. As the deadline nears, you may be realizing that under the new MDR, language and translations play a much more important role in regulatory compliance than before.
How does EU MDR impact your translation system?
Official Language Requirement: The new EU MDR regulation may change your current language selection requirements. Up until now, individual EU Member States determined their own language selection. This changes under the new MDR, which requires that all regulated medical device content be available in all 24 official languages of the Member States where the devices are distributed. If you haven’t already translated into all 24 languages, this may significantly increase the number of languages you support.
Content requiring translation: The scope of regulated medical devices has been expanded under the new MDR: products with non-medical purposes, such as colored contact lenses, are now included. In addition, translation requirements for devices currently regulated have been modified and expanded to include documentation from the manufacturer, analysis, management, authorization, marketing and distribution of medical devices. In most cases, existing technical documentation will need to be updated or revised to match the new MDR requirements.
Timing of translations: The position of translations in your workflow will probably also be impacted by EU MDR requirements. Under previous regulations, translations were primarily performed after CE marking. Under the new MDR regulations, translations of labeling and Instructions for Use (IFUs) are required as components of the technical dossier that is submitted for review to the Notifying Bodies. This moves the translation of product documentation up in the workflow. To meet new requirements, translation will have to be an integral step in many other phases also, for example post-market surveillance.
Quality Management: The new MDR requires supply chain transparency relating to quality systems and risk management. Your Language Service Provider (LSP) will need to support you with an effective Quality Management System that takes a risk-based approach to decision-making and management of 3rd party suppliers. Although not required, your LSP’s certification to ISO 13485:2016 can demonstrate compliance in this regard.
Translation Quality: The new MDR requires precise, clear language, especially on content intended for the end user. Labeling, IFUs, safety and clinical performance information must be clearly comprehensible and easily understandable to the intended user. This applies not only to the original source language but 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 emphasis on data and use of a central European database of medical devices, EUDAMED, to capture, correlate and exchange device information in all applicable languages. Considering the different types and sources of this information and all the revisions to existing technical documentation required by the new regulation, your LSP must be able to interact with client-based Content Management Systems and have an effective Translation Management System in order to ensure accurate global changes, consistent translations, traceability of work and cost-efficient processes.
How can you make the most of the time remaining?
LSPs like Ingenuiti, who understand the new requirements of the EU MDR, will be able to proactively support you in achieving timely compliance with the new regulation. With certified ISO systems in place and trained translators at the ready, we can help you make sure that all of the necessary revisions and updates to existing documentation are applied for all of your EU markets.