First guidance on new rules for certain medical devices

February 28, 2019 – EMA has published today the first of a series of guidance documents to help applicants prepare for obligations stemming from the new EU regulations on medical devices. The new regulations introduce new roles and responsibilities for EMA and national competent authorities (NCAs) in relation to certain types of medical devices and in-vitro diagnostics. The Agency is working closely with the EU regulatory network and with stakeholders … (leggi tutto)