Tag: Export Medical Devices
Importing Medical Devices Into the United States
The European medical device (MD) market is estimated to be worth around €140 billion. It is the second biggest MD market in the world, covering 27.6% of the world market, behind only the United States. This should be encouraging to medical device companie...
Medical Device Advertising Requirements in United States
Every step of medical devices logistics importing, selling, and marketing in the EU involves stringent regulations. The industry was once governed by the Medical Device Directive (MDD), eventually amended by the current Medical Devices Regulation (MDR).
Economic Operator obligations Under The EU Medical Device
All medical devices sold in the region are required to have Unique Device Identification (UDI) numbers under the MDR.
EU MDR / IVDR Requirements 6 Medical Device Repackaging and Relabeling
This post discusses the basics of the European Union (EU) Medical Device Regulation (MDR) and In Vitro Device (IVD), which took effect on 26 May 2021. All medical device manufacturers, importers, and repackagers that operate in Europe need to comply with...
