Further analyze of the responses of the July CIRCABC survey on the capacities of notified bodies : both the staff resource and certificates issued.
Team-NB-Press-Release-July-Survey-Capacities-20180820
Factsheets for manufacturers are available on the Commission website under the title “Information for manufacturers”:
https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en md_mfr_factsheet
Analyse of the survey results launch on mid-June on CIRCABC related to transparency on designation process.
Team-NB-Press-Release-Applications-Survey-20180720
Registration of TEAM NB in the EMA stakeholders database
Team-NB is now an active member of the EMA database and will be contacted regarding EMA activities.
JAMS publishes stakeholder leaflets
The Joint Action on Market Surveillance of Medical Devices (JAMS) releases four new downloadable leaflets to help explain the purpose and expected impact of the joint action for: • Healthcare professionals • Manufacturers of medical devices • Notified bodies • Patients and consumers of medical devices. https://www.camd-europe.eu/joint-action-projects/market-surveillance-of-medical-devices-jams/
Team-NB position paper on “Points to add to contracts between Manufacturers and notified bodies”
This document is proposing template on added clauses for agreement between Manufacturers and Notified Bodies regarding the transition period. TEAM-NB-Bullet-Points
Article from Amanda Maxwell in Medtech Insight
EU Regulatory Reads, April 2018: Specific MDR Aspects Start to Come Under Fire