Posted by Michael Wonder on 28 Feb 2019
First guidance on new rules for certain medical devices
28 February 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 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 from the pharmaceutical and medical device industries, including notified bodies, to ensure a smooth transition to the new regulatory framework.
