Content
The EU Regulations 2017/745 on medical devices and 2017/746 on in-vitro MD from 2017, known as MDR and IVDR, are having deep consequences over the MedTech industry. What are the language requirements established by them? How can translation professionals be prepared to best serve MD linguistic needs? What are the profiles searched by specialized translation companies? What are the related standards? What type of documents need to be translated?
Takeaways
Understanding of MDR/IVDR language requirements
Keys to offer a translation service addressing the needs of MedTech companies
Typology of documents being translated under MDR/IVDR
References to valuable linguistic resources
Prior knowledge
Knowledge at language technology, tools and linguistic competences for translating. The target audience will be mainly translation professionals. Some knowledge of European legislation machine and the MDR or IVDR will definitely help, but it is not necessary.