Transition to the New EU CE Marking Regulation
Team-NB have been invited to speak at the event organised at Tel Aviv on December 21st. See programm joined.
Medtech Forum 2021 : Remote Audit Readiness
Following the forum that took place in April, here is a link to the article published in the MedTech Strategist Market Pathways journal. https://www.mystrategist.com/market-pathways/article/remote_audit_readiness_leaders_share_key_learnings_.html
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
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.
General assembly meeting
On October 11th general assembly meeting, Team-NB decided to suspend the audits against the Code of Conduct in order to work on the preparation of interpretations on MDR requirements in an objective of harmonisation.
In the framework of the new Medical Device Regulations,
you will find below the Team-NB members’ intention to submit their application to be designated against MDR and/or IVDR. The Team-NB notified body members have a double advantage to pass their designation audit : The peer review against the Code of Conduct which requirements are ahead of the today ones. The working groups reviewing [...]
New press release
concerning the adoption of MD draft regulations by ENVI group TEAM-NB Press Release
Survey sector
on the basis of members data are available in documents 2016
Article in Clinica by Amanda Maxwell
Overworked Notified Bodies Turn Clients Away And Demand Own 5-Yr Transition http://www.clinica.co.uk View PDF
Negotiations
between the European Parliament on the future legislation are currently taking place. In this context, TEAM-NB, wishes to highlight several points still to be discussed between the Parliament and the Council. Enclosed our Position Paper on this negotiations.