JD Supra

European Commission proposes to extend MDR transition periods to prevent shortages in medical devices

The European Commissioner for Health and Food Safety, Stella Kyriakides, has proposed measures to extend the transition rules of Medical Device Regulation (EU) 2017/745 (MDR) at the Employment, Social ...
JD Supra

The FDA Finalizes Transition Plan for Medical Device Authorizations and Policies Affected by Covid-19 PHE

The Food and Drug Administration (FDA) has announced transition plans for Emergency Use Authorization (EUA)-authorized medical devices and devices marketed pursuant to COVID-19-related guidance ...
RAPS

Pharma, device groups oppose FDA's planned drug to device transition

Pharmaceutical industry trade groups and medical device groups objected to the US Food and Drug Administration’s (FDA) plans to reclassify some products, including imaging agents, currently regulated ...