Tag: EU

US FDA announces plans to address medical device shortage risks

The US Food and Drug Administration (FDA) has issued a statement outlining measures to enhance p...

COVID-19: European Commission agrees to postpone new MDR because of pandemic

The European Commission (EC) has adopted a proposal to postpone by one year the date of applicat...

“Wait-and-see” is not an option with the new device regulations

The new EU Medical Device Regulation (MDR) was officially published on 5 May 2017 and entered in...