Position Paper on Transparency in the framework of the MDR/IVDR proposed revision of the Regulations
Team-NB members endorsed a position paper on “TRANPARENCY”. It demonstrates that notified bodies access to information available in EUDAMED is crucial to allow a rapid risk-based regulatory oversight. Team-NB-PositionPaper-Transparency-V1-20260806 [...]
Transparency in the framework of the MDR/IVDR proposed revision of the Regulations
Team-NB wrote a one-pager in the framework of the proposed revision of the regulatory framework applicable to medical devices and in vitro diagnostic devices on Transparency to ensure that Notified Bodies have [...]
Risk-adapted surveillance in the framework of the MDR/IVDR proposed revision of the Regulations
Team-NB wrote a one-pager in the framework of the proposed revision of the regulatory framework applicable to medical devices and in vitro diagnostic devices on Risk-adapted surveillance, to focus scrutiny where risks [...]
Team-NB 2nd EU Regulations Discussion Day 2026 – November 6th
Manufacturers, Regulators, Notified Bodies are invited to this forum for discussions and opportunities to optimize the system. For registration, follow the link: https://www.team-nb.org/team-nb-eu-regulations-discussion-day-2026/ More information in the agenda below. [...]
TEAM-NB
25 YEARS
46 MEMBERS