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Many medical device manufacturers located outside the European Union have been wondering what to make of Article 13 of the European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
How do we break this to you gently? OK we can't. The blunt answer is no. Starting May 26, 2021 there are some aspects of the European Medical Device Regulation (MDR 2017/745)
Medical device regulations have been on the books for decades, long before software was widely used in medical devices, and certainly well
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.”
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
A Single Registration Number is assigned to all medical device legal Manufacturers, Authorized Representatives, System/Procedure Pack Producers and Importers involved in placing
Article 13 of the EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) includes a new requirement to appoint
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...
Many medical device companies exporting to Europe have discovered that there is a new requirement to appoint an importer in the Medical Device Regulation
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