The Italian implementation decrees for Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) will come into force on September 28, 2022. These decrees will apply to all parties involved (notified bodies, economic operators and healthcare operators).
These decrees aim to:
For the official press release click here.
The prescriptions concerning Eudamed and the national database set up by the Italian Ministry of Health to supervise devices that are marketed in the territory include:
If you need a reliable medical translator to translate your technical documentation, for example, your risk analysis/management documentation, test reports, or instructions for use (IFUs), conformity certificates (also sworn certificates), etc. into Italian according to MDR/IVDR requirements, get in touch to discuss your translation needs. For additional information or a quotation, please e-mail me.
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