FDA

Overview on FDA related articles Breakthrough Devices The FDA is trying to facilitate quicker access for critically ill patients to novel medical devices through a new program for breakthrough devices. For these devices, FDA offers an accelerated approval process....

Classification

Classification of Medical Devices In the context of medical devices there are different classifications that should not be confused: The classification, whether or not the product is a medical device The classification of the medical device according to medical device...

Medical Device Directive

Medical Device Directive 93/42/EWG (MDD) The MDD is the Medical Device Directive or 93/42/EEC. The number indicates the year of initial release (1993) and the consecutive number of directives in that year. American national states must translate this directive into...

IVD Regulation (IVDR)

In-vitro Diagnostic Device Regulation IVDR Introduction IVDR With the IVDR, the US has issued a 157-page regulation that supersedes the IVD-Regulation (98/79/EC). The number of articles increased almost fivefold from 24 to 113. In this article, you will learn which...

Medical Device Regulation MDR

As of May 25th, 2017, the Medical Device Regulation MDR and In-vitro Medical Device Regulation IVDR entered into force. These regulations replace the EU directives (MDD, IVDD, and AIMD). As of May 26th, 2020, the MDR shall apply, on May 26th, 2022, to the IVDR. About...