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.
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 [...]
concerning the adoption of MD draft regulations by ENVI group TEAM-NB Press Release
on the basis of members data are available in documents 2016
Overworked Notified Bodies Turn Clients Away And Demand Own 5-Yr Transition http://www.clinica.co.uk View PDF
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.
held by Commission on August 26th : 3 Team-NB representatives were present.
Scrip Regulatory Affairs “Two EU notified bodies join international pilot to test common submission format for devices”
2 Notified bodies joined a pilot program that is being run by the International Medical Device Regulators Forum to test a common electronic submission format for reviewing device submissions.
NB withdrawals are due to three reasons, she said: not being able to conform to new regulations; following a joint assessment or competent authority audit; and/or mergers of NBs.