EU Language Translation Requirements for Medical Devices
Yes, it’s true. No, it’s not new. Yes, you need to take it more seriously than ever before. Here’s why. (Or skip the explanation and go directly to the language requirements..
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What Happens If We Don’t Appoint an EU MDR Importer?
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).
Do EU MDR Requirements Apply to You If You Have a Valid MDD CE Certificate?
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)
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
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...
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