Team NB Technical Documentation Submission Highlights and Key Changes
Team NB has released an updated version of their Position Paper on Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745. The most notable changes in the 2025 release (v2 released in 2023) include a significant rewrite of the Clinical and PMS sections, as well as the addition of information on the common pitfalls observed by NBs. Other minor updates include clarifications on wording, improved formatting, and various updates to bring the content up to date.
Of note, a call out to MDCG 2019-6 Section: 1.6.3 What is Considered “structured dialogue:” was added to highlight guidance on topics suitable for discussion with the notified body prior to submission.
Additional information on this technical documentation submission can be found in the press release issued by Team NB here.
For further information, contact us.
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