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Team-NB Position Paper on “Article 117 – NB Opinion template”

Team-NB members approved a new position paper prepared by the “Article 117” internal task force during the General Assemble Meeting with the intention to provide a template for the opinion of the Notified Body. Team-NB-PositionPaper-Article117-NB-Opinion-Template-V1

By | 2021-10-15T10:18:17+00:00 October 15th, 2021|news|0 Comments

The Commission announced that the EUDAMED UDI/Devices registration and NBs & Certificates modules have been successfully deployed in the Production environment and are now available for use

The link to join the public part of the database is: https://ec.europa.eu/tools/eudamed/#/screen/home

By | 2021-10-06T13:25:40+00:00 October 6th, 2021|news|0 Comments

Team-NB Position Paper on “implant card”

Team-NB members approved a new position paper prepared by an internal task force of 12 participants and entitled: “Team-NB Position Paper on a risk-based approach for medical devices exempted from an implant card and information to be supplied tothe patient with an implanted device per Article 18.3” Team-NB Position Paper Implant Card

By | 2021-07-21T18:44:36+00:00 July 21st, 2021|news|0 Comments

EUDAMED gradual roll-out

Here is the summary of decisions taken : • the UDI/Device module will be released in Production in September 2021. Voluntary use is possible and workable. • the NBs and Certificates module will be released in Production in September 2021 with the exception of the CECP and the Mechanism for scrutiny, which will remain in [...]

By | 2021-07-09T09:48:52+00:00 July 9th, 2021|news|0 Comments