How the New MDR/IVDR Applies to Selling Software as a Medical Device (SaMD)
Medical device regulations have been on the books for decades, long before software was widely used in medical devices, and certainly well
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How to Use the New EU Importer Symbol on Your Medical Device or IVD
Article 13 of the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) require you to list your importer "on the device or on its packaging or in a document accompanying the device.”
Hidden Cost of a Distributor Acting as Your EU MDR or IVDR Importer
As you know by now, Article 13 of the new European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) defines the specific obligations of a “new” Economic Operator in addition
What is the EUDAMED SRN (Single Registration Number)?
A Single Registration Number is assigned to all medical device legal Manufacturers, Authorized Representatives, System/Procedure Pack Producers and Importers involved in placing
EU Importer vs. Authorized Representative
Article 13 of the EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) includes a new requirement to appoint
Does an EU Medical Device Importer Take Physical Possession?
When you hear the word “importer” you might assume they are involved in the physical handling of your devices during the importation process. That’s logical...
Can We Appoint Multiple EU Importers in Compliance with the EU MDR and IVDR?
Many medical device companies exporting to Europe have discovered that there is a new requirement to appoint an importer in the Medical Device Regulation
Where Do You Need to Identify Your EU Importer on Medical Device Labeling?
By now you certainly know that Article 13 of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) require you to appoint an importer for all...
Can We Appoint Our EU Medical Device Distributor as Our Importer?
No doubt you landed here because you did some research and figured out that you now need an EU-based importer. Perhaps you have been exporting medical
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