Join date: Feb 4, 2021
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...
Jun 29, 2021 ∙ 5 min
European Language Translation Requirements for Medical Device Labeling, IFUs and Software
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...
Rene van de Zande