As of May 26, 2021, the new MDR (Medical Device Regulation 2017/745) will apply. On May 26, 2022, the In-Vitro Diagnostics Regulation (IVDR) of the European Union will become effective. These regulations will tighten many requirements for the manufacturers of medical devices, including those regarding translation and localisation: translations must be “correct and state-of-the-art” (Art. 16 MDR and Art. 16 IVDR).
Consequently, the comprehensibility and accuracy of translations – in up to 24 languages – will become increasingly important. Translation processes according to ISO 17100 give you, your customers and your Notified Bodies the assurance of receiving compliant translations.
We understand that you, as a manufacturer of medical products, are responsible for the health and safety of your customers, which is why translations of package inserts, labels or web texts are to be classified as product components. You can expect the greatest possible care from us when providing these translations.
We work exclusively with expert translators who incorporate customer-specific terminology, your company’s wording as well as relevant specifications into their translations and save them in translation databases, known as Translation Memory Systems, securely stored for you by mt-g. This helps to ensure that technical terms are then reused in future translations. Wording and terminology are continually refined through long-term cooperation, thus reducing translation costs.