News of interest to medical writers: EMA guidance for medical devices

The European Medicines Agency (EMA) has published 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 from the pharmaceutical and medical device industries, including notified bodies, to ensure a smooth transition to the new regulatory framework.

For more information, please visit the EMA medical devices page here.

The EMWA Medical Devices Special Interest Group (MD SIG) also contains many useful links for medical writers who work in the medical device industry.