EU Regulators Explain Impact of New Medical Device Regulation on Trials
New guidance from the EU tells sites and sponsors of medical device trials how to communicate with regulators about trial progress, submit safety reports, request permission for protocol amendments and draft trial summary reports under the new Medical Device Regulation (MDR) scheduled to take effect on May 26.
The 19-page document from the union’s Medical Device Coordination Group (MDCG) answers such questions as whether sponsors of trials conducted in one or more EU member states need to notify regulators of the end of the trial in each country.
A change to the investigational device would be considered a trial amendment in most cases, the guidance says, and would not require submission of a new application to regulators, but member states may decide this on a case-by-case basis.
Because the long-delayed EU’s clinical trial registry, Eudamed, will not yet be functional when the MDR takes effect, MDCG directs sponsors to register their trials initially with their national regulatory bodies, known as National Competent Authorities.
Clinical trials that started before the MDR takes effect may continue to be conducted, but EU member states must be notified in the event of a serious adverse event (SAE) or any device deficiencies occurring once the MDR takes effect.
Read the document here: https://bit.ly/3gNGYvV.