Team-PRRC 1st summit
The summit gathered representatives from different parties - Commission, NBs, ARs, Manufacturers, consultants, lawyers - from more than 10 European countries, UK and US to exchange on PRRC. photo-PRRC.jpg
New category member: Team-NB “Candidate Member”
The new “Candidate Member” category, approved during the October General Assembly, is to allow organisations (not yet NB neither against the Directives, nor the Regulations) to join the association when they applied to become NB.
TEAM-PRRC ANNUAL SUMMIT on 3-4 November 2022 in Brussels
A Team-NB representative is going to present the Notified Bodies perspectives on the Regulations implementation. More info: https://www.team-prrc.eu/articles/67843-team-prrc-annual-summit-1st-edition?header=%2Fpage%2F911804-news
Leveraging directive conformity assessments to establish compliance with the MDR requirements
The members meeting in general assembly gave their agreement in principle on the draft position paper. A vote will take place to endorse it when the document is finalised after taking into account feedback from Commission and NBO.
Data generated from ‘Off-Label’ Use of a device under the EU Medical Device Regulation 2017/745
This position paper was prepared by the Mirror-MDCG-Clinical Working group which include representatives of 11 NBs. It was circulated through CIRCABC to all NBs. It has been endorsed during the Team-NB general assembly meeting. Team-NB-PositionPaper-Off-LabelUse-V1-20221005.docx
Cyber Security position paper
This paper has been prepared thanks to the task force and endorsed during the general assembly meeting. It is a high level document. Team-NB-PositionPaper-CyberSecurity-V1-20221005.docx
Class D measures in the absence of EU Reference Laboratories
Thanks to the work of the IVD working group, Team-NB came with a Position Paper on measures for class D IVD, in the absence of EU Reference Laboratories The paper has been approved by a large majority of members during the General Assembly meeting. Team-NB-PositionPaper-InterimmeasuresVerifclassD-V1-20221005.docx
Team-NB Position Paper on BPG Technical Documentation
During Team-NB General Assembly Meeting, all the members presents voted to approve this Best Practice Guidance. Team-NB-PositionPaper-BPG-TechnicalDocEU-MDR-2017-V1-final.docx
Team-NB Position Paper on Transfer Agreement
Team-NB voted to approve this paper. Some of NBs intend to have the paper reviewed by their legal services. It has been decided to reopen paper for revision in case of significant feedback from these reviews and/or feedback based on practice with the paper. Team-NB-PositionPaper-TransferAgreement-V1-20221005.docx
Team-NB Position Paper on time to implement guidances
Thanks to the work of the MDR&Covid task force, Team-NB came with a Position Paper on “Notified Body position paper on transitional period for implementation of MDCG guidances and best practice documents” the members welcomed this paper at a very broad consensus. Team-NB-PositionPaper-Transition-for-Guidances-Standards-BestPracticeDocs-V1