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Rene van de Zande
- Oct 26, 2021
- 4 min
Yes, Manufacturers of “Legacy MDD” Medical Devices Really Do Need an EU MDR Importer….NOW
The European Medical Device Regulation (MDR 2017/745) took effect on May 26, 2021. Manufacturers holding valid Medical Devices Directive...
517 views

Edgar Kasteel
- Apr 28, 2021
- 3 min
Our device has a valid MDD CE certificate. We don't need to comply with the EU MDR right?
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...
436 views

Edgar Kasteel
- Apr 22, 2021
- 3 min
We Sell Software as a Medical Device (SaMD). Do We Need an Importer for EU MDR/IVDR Compliance?
Medical device regulations have been on the books for decades, long before software was widely used in medical devices, and certainly...
519 views

Edgar Kasteel
- Mar 18, 2021
- 2 min
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...
5,031 views

Edgar Kasteel
- Mar 15, 2021
- 2 min
Does our EU importer need to take physical possession of our medical devices?
Article 13 of the European Medical Device Regulation and In Vitro Diagnostic Regulation (IVDR) requires you to appoint an EU importer....
260 views

Edgar Kasteel
- Feb 9, 2021
- 3 min
Where do we need to identify 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...
1,633 views