Of MDR and Translations (2/6)
As you proceed with your gap analysis to the upcoming MDR, you will quickly realise, the MDR compared to the former MDD, has a slightly expanded volume of documentation but more importantly significantly raised requirements. The expected scientific quality has been drastically increased introducing advanced clinical data to support your conformity assessment procedure. A stricter rule regarding translation has been introduced and the manufacturer’s has been provided with a more detailed guidance for organising and drafting technical documents. In order to help you identifying the right timing for translating your files and the language requirements for each of them, we have created a recapitulative table.
For more information on how Baguette can help you get ready for MDR, contact us today.