Aug 30, 2019
Europe
What is IVD/IVDR In Vitro Diagnostic (IVD) medical devices are intended for examining specimens of the human body to either provide information on the physiological state of the patient or to monitor therapeutic measures. They could also be used to define the...
Read More
Jul 2, 2019
EU MDR/IVDR
European medical device regulating authority, the European Commission, issued two additional guidance. They expand on certain application aspects of Medical Device Regulation and in vitro Diagnostic Device Regulation. The new documents include important changes and...
Read More
Dec 25, 2018
EU MDR/IVDR
The European Union has established the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) as replacements to the Medical Devices Directive (MDD) and ln Vitro Diagnostic Devices Directive (IVDD), which had previously been in place for almost 25...
Read More
Jul 9, 2018
EU MDR/IVDR
Although the European Medical Devices Regulation (MDR) will not go into full effect until 2022, if your medical device company does business in the European Union, you may need to modify your labeling before then. The EU MDR has laid out requirements that further...
Read More