EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission, has issued the first revision of guidance notes to the manufacturers of Class I medical devices initially published in December 2019. In particular, the document intends to...
FDA
The Food and Drug Administration (FDA), the US medical device regulating authority, has published a notice dedicated to the pilot program for a request for designation (RFD) and pre-request for designation (Pre-RFD) electronic submissions. The document was published...
Europe
MedTech Europe, a European association of medical device manufacturers and other industry representatives, has published a call to action related to the virtual inspections of the manufacturing facilities. Virtual Audits: Regulatory Background First of all, it is...
FDA
The Food and Drug Administration (FDA) has published an updated fee schedule for medical device users – the companies applying for FDA approval for their medical devices. According to the Medical Device User Fee Amendments (MDUFA), most of the entities...
Europe
Swissmedic, a Swiss authority responsible for medical device regulations, has published an information sheet dedicated to the marketing authorization of non-conforming medical devices. In particular, the document describes the rules and procedures to be applied for...
FDA
The Food and Drug Administration (FDA) announced an exemption from premarket notification for certain Class II medical devices. FDA Exemption in Brief The FDA has published an order indicating class II medical devices to be exempt from 510(k) premarket notification...
