The adoption of Medical Device Regulation is a new step towards the improvement of the medical device regulatory framework. Regulation 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (or the MDR) replaces the Medical Device...
The Saudi medical regulating authority announced upcoming changes in their medical device regulations. These changes are occurring with the goal to harmonize regulatory requirements with those of the European Union, which will also be changing in 2020. The...
Swiss Medtech Group, the non-governmental association that represents the interests of the companies operating within the medtech industry, issued recommendations to medical device manufacturers covering issues related to gaining access to various markets within the...
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...
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...