Members exclusive access

About PascalePerspectives

This author has not yet filled in any details.
So far PascalePerspectives has created 106 blog entries.

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

Team-NB approved a new Position Paper on the requirements for the EU MDR/IVDR Notified Body Partners under the Technical Cooperation Program on Exchange of Medical DeviceQuality Management System Regulation and ISO 13485 Audit Reports (TCP III) thanks to the preparation of the TCP task force members.

Team-NB Position Paper TCP V1

By | 2020-07-27T06:48:13+00:00 July 27th, 2020|news|0 Comments