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

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  

HealthCare Without Harm association held his webinar on the topics of EUDAMED and chemicals within Devices. Oliver Bisazza (MedTech Europe) presented the situation from Industry point of view followed by Françoise Schlemmer presenting the Notified Bodies perspective. The presentations were followed by a Q&A session.

Team-NB welcomes a new member from Italy. From now on, the association has 31 members from 18 different countries.

Thanks to the work of the MDR&Covid task force, Team-NB came with a Position Paper on “Notified bodies’ paper on the application of hybrid audits to quality management system assessments under MDR/IVDR” All voters welcomed positively the Paper. Team-NB-PositionPaper-HybridAudits-V1

All the Notified Bodies designated and the concerned stakeholders have been invited to different meetings taking place on October 4th to 6th. (These meetings will take place remotely)

Health Care Without Harm (HCWH) Europe invited Team-NB representative at a webinar they organise on 27 September to discuss MDR implementation. More information : https://noharm-europe.org/

The association meeting is scheduled on October 5th

The MDCG endorsed document advised actions such as hybrid audits, organize structured dialogues with manufacturers to improve the efficiency of the conformity assessment process, and so on see more information: 14 mdcg 2022-14 position paper_actions transition mdr-ivdr    

Published for 4 weeks consultation (document accessible to https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12972-Medical-devices-reclassification-of-products-without-an-intended-medical-purpose_en