Does the RegLab ever handle medical devices or are there any plans to add that?
Does the RegLab ever handle medical devices or are there any plans to add that?
Regulatory Labelling and Medical Device are two different content types. RegLab is a specific sub-area of pharmaceutical translation regarding the approval procedures for medicinal products (drugs).
Medical Device translation does not have the same requirements. Content types for medical devices are typically manuals, instructions for use (IFU), labels, marketing/sales brochures, websites, software. There are regulations for medical devices too, but for linguists requirements are not as extensive.
For medical device regulation (MDR), we do ask that you follow official MDR terminology/wording for EU language. You can find the regulation in all required EU languages here:
https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=uriserv:OJ.L_.2017.117.01.0001.01.ENG
Regulatory Labelling and Medical Device are two different content types. RegLab is a specific sub-area of pharmaceutical translation regarding the approval procedures for medicinal products (drugs).
Medical Device translation does not have the same requirements. Content types for medical devices are typically manuals, instructions for use (IFU), labels, marketing/sales brochures, websites, software. There are regulations for medical devices too, but for linguists requirements are not as extensive.
For medical device regulation (MDR), we do ask that you follow official MDR terminology/wording for EU language. You can find the regulation in all required EU languages here:
https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=uriserv:OJ.L_.2017.117.01.0001.01.ENG