Finetuning The Art Of Leveraging Past Notified Body Assessments Of Technical Documentation
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.
You may also be interested in...
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.
Shortfalls in manufacturer technical documentation submitted to notified bodies cause delays for manufacturers and notified bodies alike. A new document from the notified body association, TEAM-NB, aims to streamline processes.
The EU Batteries Regulation is yet another legal instrument medical device manufacturers must address over the coming years alongside the core Medical Device and IVD Regulations.