Medical Translation: Ensuring Conformance with EU Regulations

Medical Translation: Ensuring Conformance with EU Regulations

Medical Translation: Ensuring Conformance with EU Regulations 5760 3840 Accelingo

Accurate Medical Translation—a Necessity for the EU Market

Any business in the medical field needs a reliable translation partner for their medical documentation translation in order to enter a foreign market. With the new EU Medical Device Regulations (MDR) that bring significant changes to the industry, it is essential to ensure compliance via accurate medical translation services.

Medical Startups Are On the Rise

According to an analysis conducted by Pitchbook for Forbes, startups in healthcare raised $2.8 billion in venture capital funding in September 2018 ranking second behind the information technology sector.

Fortune reports that there was a boom in healthcare startups with a growth of more than 200 percent in 2010–2014, with the positive tendency expected to continue. A survey by the European Startup Monitor reveals that more than half of all startups have expanded their services globally, with 21.2 percent having entered the EU market and 29.8 percent operating worldwide.

With this statistic in mind, it is essential for your healthcare startup to be fully compliant with the new regulations adopted by the EU in 2017 and entering effectively into force this spring, especially if your primary focus is medical devices.

About the New EU Medical Regulations

Medical translation requires a highly professional approach to guarantee compliance both with the various regulations and the respective well-being of the end users. One of the most important tasks of a translation agency is to ensure accuracy and up-to-date localization in line with recent legislative changes.

If you target the EU in your market penetration strategy, you are already aware of the two new regulations concerning medical devices that will reshape the framework of the industry—the European Union Medical Device Regulations (MDR) – Regulation (EU) 2017/745 and Regulation (EU) 2017/746.

The regulations affect manufacturers, importers, and distributors of medical devices by providing new requirements about labeling and packaging. Each device will have a unique device identifier (UDI), similar to that required by the FDA, that will make its registration and traceability easier. If you have localized your medical documentation for the U.S., you are probably familiar with this process and your translation agency is well-prepared for the project.

The new regulations will demand a different approach to medical translation and localization both for existing and emerging companies in the field. Close cooperation with your language service provider will help you map out your current and future translation needs and decide on the best approach for their implementation.

How to Guarantee Conformity of Your Medical Document Translation with EU Regulations?

A translation agency with experience in medical translation services will be able to provide invaluable help for the localization of medical documentation in line with the new EU regulations.

While your LSP can provide guidelines on the language requirements for the different markets within the EU, it is the Competent Authorities that will decide which piece of documentation needs to be translated in the respective language. That can include labels, conformity documentation, instructions for use, or other certification.

The new MDR provides for more detailed information to be included about the medical device and presented in the national language in a way that it is “clearly comprehensible to the intended user or patient.” This automatically means more content to be translated and localized into multiple languages depending on your existing or target markets.

To guarantee conformity with the new EU regulations, you can follow these tips when preparing your medical documentation for translation and localization:

  • You need to prepare consistent technical documentation about your product in compliance with the new regulations prior to sending the content for translation and localization. This is the base for an accurate and high-quality translation provided by your LSP.
  • When preparing the new documentation design and content, you have to write for translation and envisage text expansion in foreign language translation. You need to include all the required elements of information and your LSP will make sure that they will be properly localized in the target language.
  • Make sure that the translation agency supports different file formats and can translate documents from various systems and platforms to guarantee a smooth and quick process.

ISO Certification of the LSP

One of the important requirements of the new MDR stipulates that medical device manufacturers should have a highly efficient and effective Quality Management System in place. This also affects any work that is delegated to external contractors.

In the case of translation and localization of the medical documentation required under the regulations, the LSP is a third-party supplier that also needs to have a quality and risk assessment methodology in place.

Certification under the current ISO standard for Medical Devices—ISO 13485:2016, while not specifically required by either regulation, can prove that the translation and localization projects implemented by your translation agency are compliant with the EU regulations.

If your current LSP is not certified under ISO 13485, it is a good idea to approach them in an open conversation and see what the possibilities of such certification are as part of your long-term partnership.

Equally, you can expect your translation agency to ask about your marketing strategy and details about the EU markets your startup is targeting in order to provide more efficient medical translation services. You can find more about the process of finding the right translation and localization partner in our free white paper “40 Questions to Expect from a Translation Agency.”

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