EU MDR/IVDR
The European Commission (EC), the EU regulating authority in the sphere of medical devices, has published a detailed FAQ dedicated to the most important questions related to the Unique Device Identification (UDI) system established under the Medical Device Regulation...
FDA
The Food and Drug Administration (FDA) has published a guidance document dedicated to the cutaneous electrodes for recording purposes. In particular, the document constitutes a final version of the guidance, while the initial draft was published by the FDA in...
EU MDR/IVDR
The Medical Devices Coordination Group (MDCG) has published special guidance providing medical device manufacturers and other parties involved with additional recommendations and clarifications regarding how Article 15 of the Medical Device Regulation 2017/745 (MDR)...
FDA
The Food and Drug Administration (FDA) has published guidance dedicated to the safety and performance pathway as it applies to medical devices. Due to its legal nature, the document does not establish mandatory rules the industry representatives shall follow. It only...
FDA
The Food and Drug Administration (FDA or the Agency) has answered the most important questions related to importing, registration and listing of medical devices during the pandemic associated with the outbreak of the Coronavirus Disease 2019 (COVID-19). Importing...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission, has published guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation 2017/745...
