Explaining The EU Rules For Device Software Working With Hardware
The regulation of medical device software (MDSW) is a challenging topic given the multiple configurations in which it can be used and how it interacts with hardware. New EU guidance has just emerged.
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-five documents have been posted on the tracker since its last update.
There are 10 listings in the first group of EU reference laboratory to be named. They will not formally assess IVDs for about a year and even then only evaluate products that are in a later batch to comply with the IVD Regulation.
EU Regulatory Roundup, November 2023: Notified Body Advances But Sector Still Demands System Rethink
There is currently a melting pot of ideas concerning the future of the EU’s medtech regulatory system due to its shortfalls. All the while progress is being made, especially in the area notified bodies.