The US agency has proposed a Voluntary Malfunction Summary Reporting Program that will allow makers of an array of devices to submit Medical Device Reports in a summary, rather than individual, format to FDA. The program aims to make the MDR-reporting process more effective and give the agency clearer post-market visibility.
Makers of an array of devices will soon be able to submit Medical Device Reports in a summary format to US FDA thanks to an upcoming program that aims to make the MDR-reporting process more effective and give the agency clearer post-market visibility of problem products.
Submitting reports under the Voluntary Malfunction Summary Reporting Program "would provide the most compact and efficient reporting mechanism for streamlining...
Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.
MedTech Europe is ready to become involved and shape Europe’s Life Sciences Strategy and help drive regulatory simplification from the top to make the EU “the world’s most attractive place for life sciences by 2030.”
The UK government’s blueprint to deliver an NHS "fit for the future" was released on July 3.
