Translations for Class I medical devices- Under the new MDR regulation in force from May 2021/ May 2022 for IVDR, there are new requirements for medical devices in terms of self-certification and compliance, which also impact medical device IFU translation.
Issues such as classification (class I, II or III medical devices), or Declaration of Conformity are of outmost interest to these companies.
Approximately 47% of medical devices are considered a class I medical device, 95% of which are exempt from the regulatory process.
Class I medical devices include medical face masks, elastic bandages, examination gloves, electric toothbrushes, hospital beds, hand-held surgical instruments, digital apps used to monitor health status in home settings etc.
Many of our clients producing class I medical devices are now asking our medical translation team at Paspartu to translate their updated Declarations of Conformity.
Moreover, the new MDR requires that IFUs of medical devices are updated to reflect the new regulatory framework, which means that all updated versions of your IFUs have to be translated as well. Medical devices IFUs translation is vital for business continuation and regulatory approval. Fortunately, we can isolate the new content in your files and quote for new content alone, to save you important financial resources.
At Paspartu, we cover medical translation for all EU languages, including the most demanding languages like German, Dutch. Danish, Irish, Norwegian and Swedish, always with native medical translators and Subject Matter Experts.
Accuracy, consistency of terminology and security of information are the 3 main pillars of delivering quality medical translations- if you wish to learn more about how we check quality in your medical translations, check this: https://www.paspartutranslations.com/translation-quality-2/ !
