TEAM-NB To Roll Out Evidence Of Compliance With Extended MDR Period Rules 'Soon'
Questions about how manufacturers are going to demonstrate their legacy products may remain on the EU market beyond the former 24 May 2024 deadline have abounded. One vital instrument to demonstrate ongoing compliance is soon to be available.
You may also be interested in...
Recent experience gained on submitting technical documentation to notified bodies in a way that can speed up product assessments has led to a revision of guidance issued last October, as well as to work on a new paper to further streamline the notified body work related to this documentation.
The deadlines for legacy products under the Medical Device Regulation have changed. Here are the essentials that all medtech players need to understand in how the MDR has now been amended.
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.