Are you ready for the new translation requirements in the Medical Devices Regulation?
The Medical Devices Regulation
As of 26th May 2021, EU Medical Devices Regulation (EU MDR) will fully replace the Active Implantable Medical Devices Directive and the Medical Devices Directive. Although these regulations were first published in 2017, the grace period to implement changes is looming.
The new regulation includes some major changes, such as:
- Broadening the scope of what is considered a “medical device”. That means some devices previously considered as aesthetic products, such as coloured contact lenses, must now adhere to the new regulations.
- All technical documentation, including translations, are included as part of the test for the CE mark. Therefore, they need to be completed well in advance.
- There will be stricter post-market audits and product testing to ensure products and the documentation meet the new regulations.
What are the new translation requirements?
In terms of translation requirements, all translations that accompany medical devices, such as packaging, labels, safety information and IFUs, must now be in all 24 EU languages.
These languages are: Bulgarian, Czech, Croatian, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Italian, Irish, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovene, Spanish and Swedish.
The new translations will be required with new products and the translations for existing products will all now need updating to include all 24 languages.
Andiamo! medical devices translation
The EU Medical Devices Regulation says it is essential to choose a professional agency.
Andiamo! has specialised in medical and pharmaceutical translation for over 30 years. We are proud to be certified for ISO 13485:2016, ISO 9001:2015 and ISO 17100:2015.
We have professional medical translators for all of the required 24 EU languages. They have the knowledge and experience to translate your labels, safety information and IFUs accurately. We highly recommend our translation and revision Gold Service for all medical clients. Our medical revisers also have the same professional qualifications and experience as our medical translators. Therefore, you can rest assured that the quality will be of the highest standard.
Andiamo’s typesetting service
In addition to medical translation, Andiamo! offers a professional multilingual typesetting service. This will help streamline the translation and typesetting process for you. We’ll carefully insert all of the 24 translations into your packaging or IFU artwork. Then we’ll return your translated files either as high-resolution PDFs or in the original artwork.
Get in touch with us today on 08450 345677 to find out more about how we can help you update your medical translations in time for the EU Medical Devices Regulation deadline.
