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)
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
The Commission published Frequently asked questions on medecines and medical devices concerning sanctions adopted following Russia’s military aggression against Ukraine and Belarus'faqs-sanctions-russia-medical_en
Team-NB-PositionPaper-ConfAssessment-Multiplexassays-V1 Thanks to the work of the IVD working group, Team-NB came with a Position Paper on “Conformity assessment of multiplex assays” The paper has been approved by a large majority of members designated in the IVD sector.
