Importer of Record- What is it?
If you export devices to the European Union, United Kingdom or Switzerland, you will need to appoint an “Importer of Record.” Understandably, many...
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Medical Device Labeling Requirements in Europe
If you have been selling your medical devices or IVDs in Europe for some time, you’re probably aware of the requirements for identifying your EU Authorized...
Selling Medical Devices in Switzerland? Common Troublesome Scenarios for Manufacturers
Up until the new EU Medical Device Regulation (MDR) went into effect in May 2021, the European Union and Switzerland operated under...
CH-REP and Importer Now Needed When Exporting Medical Devices to Switzerland
Selling in Europe used to be so simple. As recently as May 2021, CE Marking granted you unfettered access to all European Union countries...
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