The Challenges of Harmonising Device Classification
This article was originally published in RAJ Devices
The publication of final Global Harmonization Task Force guidance on the principles of medical device classification and conformity assessment (see pages 357-358) marks a significant milestone on the road to harmonisation. If the recommendations in the two documents1,2 are followed, the diversity of classification and conformity assessment schemes worldwide will decrease.
You may also be interested in...
The data compares the sensitivity of almost 200 diagnostics against a standardized set of samples.
The sale of BTG Specialty Pharmaceuticals to two affiliates of European specialty firm SERB leaves Boston Scientific with BTG’s interventional oncology and vascular products.
The proposed rule from the US HHS that would require its agencies to review all regulations every 10 years could distract an incoming Biden administration from the COVID-19 pandemic and will “wreak havoc” on Medicare, a senior policy analyst for the Center on Budget and Policy Priorities says.