The CE mark is your medical device’s passport to the European Union (EU). The CE mark has been affectionately given said nickname because CE mark approval can make or break your launch in member countries. The EU MDR directives certify your device’s adherence to health, safety and environmental requirements. Translations are critical to successful compliance, especially with the updated directives.
The newly updated EU MDR directives significantly emphasize translating documentation to receive the coveted CE mark approval. Doing so has been beneficial for multiple reasons: preserving the cultures of the countries you sell and market in and making sure your audience can understand and adhere to instructions for use, labels, and more documentation. These accurate and accurate translations can be potentially life-saving to your device’s users and patients.
With these significant changes, you may need to be concerned about what languages are required for translation or what materials need to be translated for your upcoming product release. If it hasn’t been prioritized yet, translation and localization should also be implemented for products currently on the market.
Why do you need CE Mark Approval?
To put it simply, obtaining your CE Mark is the first step to selling your medical device in the EU. All manufacturers in Europe and abroad must establish CE marking to market and sell their devices in participating member countries successfully and legally. The new directives focus on the translation of documentation to ascertain the coveted CE mark for your device means that there are now more languages and documents required for translation than ever before.
The Evolving Role of Translation in CE Marking
Now more than ever, it is more important to work with an experienced language services partner (LSP) with the updated directives. Commonly, manufacturers used to prioritize the ‘Big Five.’ Doing so will leave out 19 other languages required by the updated directives. With 33 participating countries, there are 24 official languages that product and device materials must be translated into. Working with an experienced LSP will help ensure that your message is delivered accurately in each required language.
Controlling the quality of your finished product should permeate the entire translation process. You can help ensure quality translations by understanding what needs to be translated and localized, reviewing and editing your source materials for translation, understanding all of the languages required for translation and what you already have and ensuring quality management from your LSP.
So, what does that mean now for CE mark translation? More and more medical device manufacturers are finding themselves in an endless loop of questions and concerns.
Morningside has created a brand new guide to support your device’s release with that in mind. Download our “CE Mark Translation: Your Passport to the EU” Guide to answer your questions:
- What are the Translation Requirements?
- How do I maintain Translation Quality?
- What Countries Require Translation?
- What Languages are Required?
In our new guide, you can learn the answers to the questions above and feel more confident about your organization’s practices and securing your CE mark. Once you better understand what documentation will be required for translation and localization, you can ensure your translated materials are as accurate as in your source document and convey the same important or even life-saving messaging.
Download our “CE Mark Translation: Your Passport to the EU” today to learn the translation requirements for CE marking and how Morningside can support your next product launch.
We’ve provided high-quality medical translation services at Morningside for over 20 years. Our quality assurance process includes many layers of controls, including editing and proofing with built-in redundancies. To learn more about our high-quality translations, contact us today.